Implantation of repair devices in the heart

ABSTRACT

Apparatus is provided, including a plurality of helical tissue anchors and an intracardiac annuloplasty structure defining a plane for placement on a heart valve annulus. The annuloplasty structure includes a plurality of compressible subunits, and a plurality of anchor mounts alternately disposed with respect to the plurality of compressible subunits. Each anchor mount (a) defines at least one opening for passage therethrough of a respective helical tissue anchor, (b) defines a path for passage therethrough of the helical tissue anchor, the path being aligned along an axis that is at a non-zero angle with respect to the plane of the annuloplasty structure, and (c) provides a structural element in the path for corkscrewing a distal portion of the helical tissue anchor therearound. Other embodiments are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of U.S. Ser. No. 15/144,127 toGross et al., entitled, “Implant and anchor placement,” filed May 2,2016, which published as US 2017/0000609, and which is a continuation ofU.S. patent application Ser. No. 14/551,951 to Gross et al., entitled,“Implant and anchor placement,” filed Nov. 24, 2014, which issued asU.S. Pat. No. 9,351,830, and which:

(a) is a continuation of U.S. patent application Ser. No. 12/996,954 toGross et al., entitled, “Annuloplasty devices and methods of deliverytherefor,” filed Mar. 24, 2011, which published as US 2011/0166649,which issued as U.S. Pat. No. 9,192,472 and which is a US national phaseapplication of PCT Patent Application PCT/IL2009/000593 to Gross et al.,entitled, “Annuloplasty devices and methods of delivery therefor,” filedJun. 15, 2009, which published as WO 10/004546, which claims priorityfrom U.S. Provisional Patent Application 61/132,295 to Gross et al.,entitled, “Annuloplasty devices and methods of delivery therefor,” filedJun. 16, 2008; and

(b) is a continuation-in-part of U.S. patent application Ser. No.11/950,930 to Gross et al., entitled, “Segmented ring placement,” filedDec. 5, 2007, which published as US 2008/0262609, which issued as U.S.Pat. No. 8,926,695, and which claims priority from:

-   -   (i) U.S. Provisional Patent Application 60/873,075 to Gross et        al., entitled, “Mitral valve closure techniques,” filed Dec. 5,        2006;    -   (ii) U.S. Provisional Patent Application 60/902,146 to Gross et        al., entitled, “Mitral valve closure techniques,” filed on Feb.        16, 2007; and    -   (iii) U.S. Provisional Patent Application 61/001,013 to Gross et        al., entitled, “Segmented ring placement,” filed Oct. 29, 2007.

All of these applications are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates in general to valve repair. Morespecifically, the present invention relates to percutaneous repair of amitral valve of a patient.

BACKGROUND OF THE INVENTION

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

US 2007/0299424 to Cumming et al. describes a catheter assembly includesan inner liner made of flexible material and an outer layer having asteering mechanism. The steering mechanism includes at least one flatwire and a corresponding lumen through which the flat wire may travel.The steering mechanism may also include at least one pull ring to whichthe flat wires are attached. A layer of heat shrink material mayencompass the outer layer. A braided wire assembly, which may have abraid density that varies along the length of the catheter, may also beprovided in the outer layer. The overall cross-section of the catheterassembly is preferably substantially circular. A catheter shaft mayinclude a plurality of segments of differing hardness characteristics.The outer layer typically comprises a melt processing polymer such thatthe catheter assembly may be laminated using heat.

PCT Publication WO 96/40344 to Stevens-Wright et al. describes abidirectional steering catheter comprising a distal electrode assembly,a flexible tip assembly, an elongated shaft having a central lumenrunning the length of the shaft, and a handle/actuator. A plurality ofring electrodes are attached to the surface of the flexible tipassembly. Signal wires running the length of the catheter areelectrically connected to each ring electrode. At least two pull cableshaving first and second ends extend distally through the central lumen.The first end of each pull cable is attached to the handle/actuator. Thesecond end of each pull cable is attached to the distal electrodeassembly, such that the distal electrode assembly may be moved between afirst and second position within a single plane by manipulating thehandle/actuator. At least two reinforcement members are located insidethe flexible tip assembly. Each reinforcement member has a proximalsection, a middle section and a distal section. Each proximal sectionhas a larger diameter than each middle section, thus being stiffer thanthe middle section. This variable stiffness along the length of eachreinforcement member distributes stresses evenly along the length of thetip assembly.

US 2005/0004668 to Aklog et al. describes implantable devices andmethods for the repair of a defective cardiac valve. The implantabledevices include an annuloplasty ring and a restraining and/or aremodeling structure or mechanism. The annuloplasty ring functions toreestablish the normal size and shape of the annulus bringing theleaflets in proximity to each other. A device having a remodelingstructure further facilitates remodeling of the valve but allows the useof a flexible ring. The restraining structure functions to restrain theabnormal motion of at least a portion of the valve being repaired. Therestraining and remodeling structures may include at least one strutacross the interior of the circumference of the ring.

US 2005/0171601 to Cosgrove describes an annuloplasty repair segment andtemplate for heart valve annulus repair. The elongate flexible templatemay form a distal part of a holder that also has a proximal handle.Alternatively, the template may be releasably attached to a mandrel thatslides within a delivery sheath, the template being released from theend of the sheath to enable manipulation by a surgeon. A tetherconnecting the template and mandrel may also be provided. The templatemay be elastic, temperature responsive, or multiple linked segments. Thetemplate may be aligned with the handle and form a two- orthree-dimensional curve out of alignment with the handle such that theannuloplasty repair segment attached thereto conforms to the curve. Thetemplate may be actively or passively converted between its straight andcurved positions. The combined holder and ring are suited forminimally-invasive surgeries in which the combination is delivered to animplantation site through a small access incision with or without acannula, or through a catheter passed through the patient's vasculature.

U.S. Pat. No. 6,102,945 to Campbell describes a support ring for anatural human heart valve, including a first ring portion havingopposite terminal ends and a second ring portion having oppositeterminal ends. An interconnector extends through and interconnects thefirst and second ring portions, to maintain the opposite terminal endsof the first ring portion adjacent the opposite terminal ends of thesecond ring portion, to form a segmented ring having a first and asecond interface between the first and second ring portions. The firstring portion is of a greater length than the second ring portion. Thering portions are separable by severing the interconnector at the firstand second interfaces, thus producing two variable size ring segments.

U.S. Pat. No. 5,593,424 to Northrup III describes an apparatus andmethod for reducing the circumference of a vascular structure comprisingthe steps of providing a plurality of sutures and a plurality ofdiscrete suture support segments of a biocompatible, inert material.Each suture support segment has at least two suture holes spaced apredetermined distance apart. The method includes individually suturingeach discrete suture support segment to the vascular structure with oneof the plurality of sutures by effecting a horizontal mattress(U-shaped) suture along the vascular structure through a length oftissue of the vascular structure such that the length (D′) of tissuesutured is greater than distance (D); and tightening and tying off thesuture, whereby each sutured suture support segment creates animbrication in the vascular structure, thereby reducing thecircumference thereof. A biocompatible, inert stabilizing material isdescribed as being optionally affixed over the suture support segmentsand the vascular structure prior to tying off the suture to stabilizethe interval between the suture support segments and eliminate directexposure of the segmented apparatus to blood.

The following patents and patent applications may be of interest:

EP Patent EP 06/14342 to Pavcnik et al.

EP Patent EP 10/06905 to Organ

PCT Publication WO 00/22981 to Cookston et al.

PCT Publication WO 01/26586 to Seguin

PCT Publication WO 01/56457 to Pruitt

PCT Publication WO 03/047467 to Cosgrove et al.

PCT Publication WO 04/103434 to Martin et al.

PCT Publication WO 05/046488 to Douk et al.

PCT Publication WO 06/012013 to Rhee et al.

PCT Publication WO 06/012038 to Shaoulian et al.

PCT Publication WO 06/086434 to Powell et al.

PCT Publication WO 06/097931 to Gross et al.

PCT Publication WO 06/105084 to Cartledge et al.

PCT Publication WO 07/011799 to Navia et al.

PCT Publication WO 07/121314 to Rafiee et al.

PCT Publication WO 07/136981 to Cumming et al.

PCT Publication WO 96/39963 to Abela et al.

PCT Publication WO 97/01369 to Taylor et al.

PCT Publication WO 98/46149 to Organ

U.S. Pat. No. 3,656,185 to Carpentier

U.S. Pat. No. 4,961,738 to Mackin

U.S. Pat. No. 5,306,296 to Wright et al.

U.S. Pat. No. 5,325,845 to Adair

U.S. Pat. No. 5,716,370 to Williamson, I V et al.

U.S. Pat. No. 5,855,614 to Stevens et al.

U.S. Pat. No. 6,074,401 to Gardiner et al.

U.S. Pat. No. 6,524,338 to Gundry

U.S. Pat. No. 6,533,772 to Sherts et al.

U.S. Pat. No. 6,569,198 to Wilson et al.

U.S. Pat. No. 6,619,291 to Hlavka et al.

U.S. Pat. No. 6,626,899 to Houser et al.

U.S. Pat. No. 6,629,534, PCT Publication WO 06/116558 and US2004/0039442 to St. Goar et al.

U.S. Pat. No. 6,752,813 to Golfarb et al.

U.S. Pat. No. 6,764,510 to Vidlund et al.

U.S. Pat. No. 6,893,459 to Macoviak

U.S. Pat. No. 6,918,917 to Nguyen et al.

U.S. Pat. No. 6,926,730 to Nguyen et al.

U.S. Pat. No. 6,986,775 to Morales et al.

U.S. Pat. No. 7,004,176 to Lau

U.S. Pat. No. 7,101,395 to Tremulis et al.

U.S. Pat. No. 7,150,737 to Purdy et al.

U.S. Pat. No. 7,172,625 to Shu et al.

U.S. Pat. No. 7,175,660 to Cartledge et al.

U.S. Pat. No. 7,220,277 to Arru et al.

U.S. Pat. No. 7,226,467 to Lucatero et al.

US 2001/0021874 to Capentier

US 2002/0198586 to Inoue

US 2003/0050693 to Quijano et al.

US 2003/0078465 to Pal et al.

US 2003/0114901 to Loeb et al.

US 2003/0191528 and U.S. Pat. No. 6,805,711 to Quijano et al.

US 2003/0199974 to Lee et al.

US 2004/0127983 to Mortier et al.

US 2004/0138744 to Lashinski et al.

US 2004/0148021 to Cartledge et al.

US 2004/0193191 to Starksen et al.

US 2004/0236419 to Milo

US 2004/0243227 to Starksen et al.

US 2004/0260394 to Douk et al.

US 2005/0055038 to Kelleher et al.

US 2005/0096740 to Langberg et al.

US 2005/0222678 to Lashinski et al.

US 2005/0288778 to Shaoulian et al.

US 2005/0288781 to Moaddeb et al.

US 2006/0095009 to Lampropoulos et al.

US 2006/0195134 to Crittenden

US 2006/0282161 to Huynh et al.

US 2006/0247763 to Slater

US 2007/0080188 to Spence et al.

US 2007/0244556 to Rafiee et al.

US 2007/0299424 to Cumming et al.

US 2008/0027483 to Cartledge et al.

US 2004/0148019 and US 2004/0148020 to Vidlund et al.

US 2004/0260393 to Randert et al. and US 2004/0127982 to Machold et al.

US 2005/0010287 and 2004/0138745 to Macoviak et al.

The following articles may be of interest:

O'Reilly S et al., “Heart valve surgery pushes the envelope,” MedtechInsight 8(3): 73, 99-108 (2006)

Dieter R S, “Percutaneous valve repair: Update on mitral regurgitationand endovascular approaches to the mitral valve,” Applications inImaging, Cardiac Interventions, Supported by an educational grant fromAmersham Health pp. 11-14 (2003)

Swain C P et al., “An endoscopically deliverable tissue-transfixingdevice for securing biosensors in the gastrointestinal tract,”Gastrointestinal Endoscopy 40(6): 730-734 (1994)

Odell J A et al., “Early Results of a Simplified Method of Mitral ValveAnnuloplasty,” Circulation 92:150-154 (1995)

SUMMARY OF THE INVENTION

In some embodiments of the present invention, systems and surgicalmethods are provided for repair of a dilated mitral valve of a patient.Typically, an annuloplasty structure, e.g., at least one elongatesegment of an annuloplasty ring, is transcatheterally advanced toward anatrial surface of an annulus of the mitral valve, using a percutaneoustranscatheter approach. In some embodiments, the annuloplasty structureis positioned at the annulus using a minimally-invasive approach, e.g.,intercostal access. In some embodiments of the present invention,systems and methods are provided for repairing the valve of the patientusing an open-heart procedure. For embodiments in which the annuloplastystructure is transcatheterally advanced toward the annulus, theannuloplasty structure assumes (1) a linear configuration having firstand second ends as it is advanced transcatheterally toward the leftatrium of the patient, and (2) a closed configuration, e.g., asubstantially ring-shaped or “D”-shaped configuration, once deployedwithin the left atrium of the patient.

In some embodiments, the annuloplasty structure has a longitudinal axiswhen disposed in a linear state thereof and comprises one or more, e.g.,a plurality, of subunits that are compressible along the longitudinalaxis of the annuloplasty structure. Typically, the annuloplastystructure comprises one or more, e.g., a plurality, of anchor mountswhich are each configured to facilitate anchoring of the annuloplastystructure to the annulus of the patient.

Typically, the annuloplasty structure is shaped to define asubstantially tubular structure which defines at least one hollow lumenconfigured for passage therethrough of a ratchet mechanism and/or atleast one contracting element, e.g., wire or cable. In some embodiments,the annuloplasty structure is shaped to define a first lumen for passagetherethrough of the ratchet mechanism and a second lumen for passagetherethrough of the at least one contracting wire.

Typically, the ratchet of the ratchet mechanism is shaped to define anelongate structure shaped to define a plurality of engaging structures,e.g., holes, slots, grooves, etc., therealong. The engaging structuresmaintain various locked configurations of the annuloplasty structure. Asthe annuloplasty structure is advanced toward a heart of the patient,the annuloplasty structure is shaped to define a substantially linearconfiguration having first and second ends. Once the annuloplastystructure has been positioned within the atrium of the patient, thecontracting wire is pulled, thereby drawing together the respective endsof the ratchet such that the annuloplasty structure, in turn, assumes agenerally circular configuration. Ultimately, the ratchet mechanismlocks in place the respective ends of the ratchet, thereby maintainingan adjusted perimeter of the annuloplasty structure.

In some embodiments of the present invention, a delivery system isprovided for positioning and anchoring of the annuloplasty structuresdescribed herein to the annulus of the patient. The delivery systemcomprises an advancement catheter housing (a) the annuloplasty structurein a distal portion thereof, and (b) a steerable catheter disposedproximally with respect to the annuloplasty structure. A plurality ofguide members are reversibly coupled to the annuloplasty structure andto the steerable catheter. These guide members facilitate steering ofthe steerable catheter toward specific locations along the annuloplastystructure. Typically, by pulling on the proximal end of a given guidemember, the distal end of the catheter is steered toward a givenlocation of annuloplasty structure.

Once the distal end of the catheter is disposed in proper orientationwith respect to the given location along the annuloplasty structure, ananchoring device, e.g., an anchor or a suture, is delivered through thesteerable catheter and toward the given location. The annuloplastystructure is then anchored to the annulus via the anchoring device.Thus, the steerable catheter and guide members facilitatetarget-specific anchoring of the annuloplasty structure to the annulus.

In some embodiments, the anchoring device comprises a helical anchorconfigured to be corkscrewed into the annulus of the patient. In someembodiments, the anchoring device comprises an anchor configured toassume a predetermined shape once it emerges from within the distal endof the catheter.

In some embodiments, the annuloplasty structure is shaped to define asingle tubular element having first and second ends which meet and forma ring structure once inside the left atrium and manipulated by theoperating physician. In some embodiments, the annuloplasty structurecomprises at least two discrete hollow ring segments which are eachanchored at respective positions along the annulus circumference of themitral valve. In either embodiment, the contracting wire functions as adrawstring to pull the segment(s) into proper orientation once thesegment(s) has been anchored to the annulus.

Using real-time monitoring, tactile feedback and optionally incombination with fluoroscopic imaging, the contracting wire is thenpulled. Consequently, the leaflets are drawn toward one another inaccordance with the level of dilation of the preoperative mitral valve.Thus, generally, the normal structural configuration is returned to theleaflets, effecting a reduction in mitral valve perimeter/size and invalve regurgitation.

In some embodiments of the present invention, a delivery tool isprovided for use during an open-heart procedure in order to anchor tothe annulus the annuloplasty structures described herein. The handle ofthe tool is coupled to a plurality of hollow-lumen tubes. The respectiveproximal ends of tubes are accessible from a proximal portion of thehandle, and the respective distal portions of the tubes are attached tothe annuloplasty structure at respective locations thereof. Theannuloplasty structure is advanced by the tool and toward the annuluswhile assuming its closed configuration. Once positioned along theannulus, a respective anchoring device is advanced through each of thetubes, through the annuloplasty structure, and subsequently into thetissue of the annulus.

Particular embodiments are described herein for implementing thesetechniques.

There is therefore provided, in accordance with respective embodimentsof the present invention, the following inventive concepts:

1. Apparatus, including:

a tube shaped to define a tube lumen;

at least one implant reversibly coupled to the tube, and configured forimplantation within a body of a patient; and

two or more longitudinal guide members disposed at least in part along adistal portion of the tube, the longitudinal guide members having distalportions thereof configured to be reversibly coupled to the implant, andarranged such that application of a force to a first one of thelongitudinal guide members steers the distal portion of the tube towarda first location along the implant, and application of a force to asecond one of the longitudinal guide members steers the distal portionof the tube toward a second location along the implant.

2. The apparatus according to inventive concept 1, wherein the implantincludes an annuloplasty structure.

3. The apparatus according to inventive concept 1, wherein the implantincludes a braided mesh.

4. The apparatus according to inventive concept 1, wherein the implantincludes at least one subunit that is compressible along a longitudinalaxis of the implant.

5. The apparatus according to inventive concept 1, wherein the implantis configured for transcatheter advancement into a body cavity of thepatient.

6. The apparatus according to inventive concept 1, wherein the implantis configured for transcatheter advancement into an atrium of a heart ofthe patient.

7. The apparatus according to inventive concept 1, wherein the apparatusfurther includes a housing configured to surround at least a portion ofthe tube, the housing being shaped to define one or more channelsconfigured for passage therethrough of the two or more longitudinalguide members, and wherein the housing is configured to moverotationally with respect to a longitudinal axis of the tube.8. The apparatus according to inventive concept 7, wherein the housingis shaped to define two or more channels, wherein each channel isconfigured for passage therethrough of a respective one of the two ormore longitudinal guide members.9. The apparatus according to inventive concept 1, wherein the implantincludes at least one elongate segment.10. The apparatus according to inventive concept 9, wherein the elongatesegment includes a shape-memory alloy, the alloy being configured toassume a curved configuration once the segment has been advanced into anatrium of a heart of the patient.11. The apparatus according to inventive concept 9, wherein the elongatesegment includes a ratchet mechanism including a body portion, a firstend shaped to define at least one first engaging structure, and a secondend shaped to define at least one second engaging structure configuredto engage the first engaging structure.12. The apparatus according to inventive concept 11, wherein:

the body portion is shaped to define at least one tubular body portionhaving at least one lumen therein,

the apparatus further includes a wire disposed at least in part withinthe lumen of the body portion, and

the tubular body portion is configured to be advanced toward a leftatrium of the patient in a generally straight configuration andsubsequently to assume a curved configuration in response to acontracting force applied thereto by contraction of the wire.

13. The apparatus according to inventive concept 11, wherein:

the body portion is shaped to define a flat body portion,

the apparatus further includes a wire disposed at least alongside thebody portion, and

the elongate segment is configured to be advanced toward a left atriumof the patient in a generally straight configuration and subsequently toassume a curved configuration in response to a contracting force appliedthereto by contraction of the wire.

14. The apparatus according to inventive concept 9, wherein:

the elongate segment is shaped to define an elongate tube having a lumentherein, and

the apparatus further includes a ratchet mechanism configured to bedisposed within the lumen of the elongate segment, the ratchet mechanismincluding a body portion, a first end shaped to define at least onefirst engaging structure, and a second end shaped to define at least onesecond engaging structure configured to engage the first engagingstructure.

15. The apparatus according to inventive concept 14, the apparatusfurther includes a wire disposed at least in part within the lumen ofthe elongate segment, wherein the elongate segment is configured to beadvanced toward a left atrium of the patient in a generally straightconfiguration and subsequently to assume a curved configuration inresponse to a contracting force applied thereto by contraction of thewire.16. The apparatus according to inventive concept 15, wherein the ratchetmechanism is configured to be advanced toward the left atrium of thepatient in a generally straight configuration and subsequently to assumea curved configuration in response to the contracting force.17. The apparatus according to inventive concept 15, wherein, inresponse to the contracting force, the wire is configured to drawtogether opposing ends of the ratchet mechanism and opposing ends of theelongate segment, and wherein the ratchet mechanism is configured tomaintain respective first ratcheted perimeters of the elongate segmentand the ratchet mechanism. 18. The apparatus according to inventiveconcept 17, wherein, in response to an additional contracting force byadditional contraction of the wire, the wire is configured to contractthe ratchet mechanism and the elongate segment to respective secondratcheted perimeters thereof, each second ratcheted perimeter beingsmaller than the respective first ratcheted perimeters, and wherein theratchet mechanism is configured to maintain the respective secondratcheted perimeters of the ratchet mechanism and the elongate segment.19. The apparatus according to inventive concept 9, wherein the elongatesegment includes first and second segments configured for simultaneousadvancement toward an atrium of a heart of the patient.20. The apparatus according to inventive concept 19, wherein the firstand second segments are configured to be advanced toward the atrium ofthe patient in a generally straight configuration and subsequently toassume a curved configuration.21. The apparatus according to inventive concept 19, wherein the firstand second segments include a shape-memory alloy, the alloy beingconfigured to assume a curved configuration once the segments have beenadvanced into the atrium of the patient.22. The apparatus according to inventive concept 9, wherein the elongatesegment includes two or more anchor mounts each having longitudinal axesthereof that are transverse to a longitudinal axis of the elongatesegment, each mount shaped to provide a channel aligned along thelongitudinal axis of the respective anchor mount that is transverse tothe longitudinal axis of the anchor mount.23. The apparatus according to inventive concept 22, wherein applicationof the force to the first one of the longitudinal guide members steersthe distal portion of the tube toward a first one of the two or moreanchor mounts, and wherein application of the force to the second one ofthe longitudinal guide members steers the distal portion of the tubetoward a second one of the two or more anchor mounts.24. The apparatus according to inventive concept 22, wherein theelongate segment includes at least one subunit disposed between the twoor more anchor mounts, the subunit being compressible along thelongitudinal axis of the elongate segment.25. The apparatus according to inventive concept 22, wherein arespective one of the two or more longitudinal guide members isreversibly coupled to each of the two or more anchor mounts.26. The apparatus according to inventive concept 25, wherein a distalend of each of the two or more longitudinal guide members is reversiblycoupled to a lateral wall of a respective one of the two or more anchormounts.27. The apparatus according to inventive concept 25, wherein:

the elongate segment is shaped to define an elongate tube having a lumenthereof,

the two or more anchor mounts are each shaped to define at least onelumen having a longitudinal axis thereof aligned in parallel with alongitudinal axis of the lumen of the elongate tube, and

the apparatus further includes a ratchet mechanism configured to bedisposed within the lumen of the elongate segment and within respectivelumens of the two or more anchor mounts, the ratchet mechanism includinga body portion, a first end shaped to define at least one first engagingstructure, and a second end shaped to define at least one secondengaging structure configured to engage the first engaging structure.

28. The apparatus according to inventive concept 27, further comprisinga wire disposed at least in part within the lumen of the elongatesegment and within respective lumens of the two or more anchor mounts,wherein the elongate segment is configured to be advanced toward anatrium of a heart of the patient in a generally straight configurationand subsequently to assume a curved configuration in response to acontracting force applied thereto by contraction of the wire.29. The apparatus according to inventive concept 28, wherein the ratchetmechanism is configured to be advanced toward the atrium of the patientin a generally straight configuration and subsequently to assume acurved configuration in response to the contracting force.30. The apparatus according to inventive concept 28, wherein, inresponse to the contracting force, the wire is configured to drawtogether opposing ends of the ratchet mechanism and opposing ends of theelongate segment, and wherein the ratchet mechanism is configured tomaintain respective first ratcheted perimeters of the ratchet mechanismand the elongate segment.31. The apparatus according to inventive concept 30, wherein, inresponse to an additional contracting force by additional contraction ofthe wire, the wire is configured to contract the ratchet mechanism andthe elongate segment to respective second ratcheted perimeters thereof,each second ratcheted perimeters being smaller than the respective firstratcheted perimeters, and wherein the ratchet mechanism is configured tomaintain the respective second ratcheted perimeters of the ratchetmechanism and the elongate segment.32. The apparatus according to inventive concept 25 a bar configured tobe disposed within the channel.33. The apparatus according to inventive concept 32, wherein the bar isdisposed within the channel angularly with respect to the longitudinalaxis of the channel.34. The apparatus according to inventive concept 33, wherein the bar isdisposed within the channel substantially parallel to the longitudinalaxis of the elongate segment.35. The apparatus according to inventive concept 25, further includingat least one anchor configured to be advanced through the lumen of thetube, wherein the anchor is configured to be advanced through thechannel of a first one of the two or more anchor mounts in response tosteering the distal portion of the tube toward the anchor mount byapplying the force to the first one of the longitudinal guide members.36. The apparatus according to inventive concept 35, wherein the anchorincludes a pointed distal tip.37. The apparatus according to inventive concept 35, wherein thelongitudinal guide member is configured to be decoupled from the anchormount subsequent to the anchoring of the anchor to an annulus.38. The apparatus according to inventive concept 35, wherein the anchoris configured to assume a first configuration as it is advanced throughthe channel and to assume a second configuration as it is implantedwithin tissue of the patient.39. The apparatus according to inventive concept 38, wherein the anchoris configured to assume a straight configuration as it is advanceddistally through the channel and to assume a curved configuration as itis implanted within tissue of the patient.40. The apparatus according to inventive concept 39, wherein the anchoris configured to assume a straight configuration as it is advanceddistally through the channel and wherein a portion thereof is configuredto curve proximally as it is implanted within tissue of the patient.41. The apparatus according to inventive concept 35, wherein the anchorincludes a helical element at a distal portion thereof, the helicalelement shaped to define a proximal end of the helical element and adistal end of the helical element.42. The apparatus according to inventive concept 41, further includingan advancement structure having a distal tip thereof, wherein at least aportion of the proximal end of the helical element is configured to becoupled to the distal tip of the advancement structure.43. The apparatus according to inventive concept 42, wherein the helicalelement is shaped to define a first number of proximal rotationalsubunits and a second number of distal rotational subunits, and whereinthe proximal rotational subunits are wrapped around the distal tip ofthe advancement structure.44. The apparatus according to inventive concept 43, wherein theproximal rotational subunits are coupled to the distal tip of theadvancement structure by a first frictional force.45. The apparatus according to inventive concept 44, wherein the secondnumber is greater than the first number.46. The apparatus according to inventive concept 45, wherein theadvancement structure is configured to be rotated and, in response tothe rotation, the distal rotational subunits are configured to beimplanted within an annulus of the patient.47. The apparatus according to inventive concept 46, wherein at least aportion of the distal tip is shaped to define a protrusion disposedadjacent to the proximal end of the helical element, the protrusionbeing configured to apply a circumferentially-directed force to theproximal end of the helical element as the advancement structure isrotated.48. The apparatus according to inventive concept 46, wherein during therotation of the advancement structure:

the proximal rotational subunits are configured to slide distally alongthe distal tip of the advancement structure, and

in response to the sliding, a portion of the first number of proximalrotational subunits remains wrapped around the distal tip of theadvancement structure.

49. The apparatus according to inventive concept 48, wherein a number ofproximal rotational subunits in the portion is less than the firstnumber of proximal rotational subunits.

50. The apparatus according to inventive concept 41, wherein:

the helical element is shaped to define at least two adjacent distalrotational subunits and at least two adjacent proximal rotationalsubunits, and

a distance between the two adjacent distal rotational subunits isgreater than a distance between the two adjacent proximal rotationalsubunits.

51. The apparatus according to inventive concept 50, further including abar configured to be disposed within the channel.

52. The apparatus according to inventive concept 50, wherein the bar isdisposed within the channel angularly with respect to the longitudinalaxis of the channel.

53. The apparatus according to inventive concept 52, wherein the bar isdisposed within the channel substantially parallel to the longitudinalaxis of the elongate segment.

54. The apparatus according to inventive concept 52, wherein thedistance between the distal rotational subunits enables the distalrotational subunits to be corkscrewed around the bar and subsequentlyinto an annulus of the patient.

55. The apparatus according to inventive concept 52, wherein a diameterof the bar is greater than the distance between the two adjacentproximal rotational subunits and less than the distance between the twoadjacent distal rotational subunits.

56. The apparatus according to inventive concept 52, wherein thedistance between the proximal rotational subunits restricts the proximalrotational subunits from being corkscrewed around the bar and into anannulus of the patient.

57. Apparatus, including:

a tube shaped to define a tube lumen;

at least one implant reversibly coupled to the tube and configured forimplantation within a body of a patient; and

one or more longitudinal guide members disposed at least in part along adistal portion of the tube, the one or more longitudinal guide membershaving a distal portions thereof configured to be reversibly coupled tothe implant, and arranged such that application of a force to the one ormore longitudinal guide members steers the distal portion of the tubetoward a first location along the implant.

58. A method for repairing a valve of a body of a patient, the valveincluding an annulus and at least first and second leaflets, including:

advancing a tube shaped to define a tube lumen toward the valve of thepatient;

advancing toward the valve at least one annuloplasty structurereversibly coupled to the tube and at respective locations thereof totwo or more longitudinal guide members at respective distal portionsthereof, the longitudinal guide members being disposed at least in partalong a distal portion of the tube;

positioning the annuloplasty structure against the annulus of thepatient;

steering the distal portion of the tube toward a first location alongthe annuloplasty structure by pulling a first one of the two or morelongitudinal guide members; and

steering the distal portion of the tube toward a second location alongthe annuloplasty structure by pulling a second one of the two or morelongitudinal guide members.

59. The method according to inventive concept 58, wherein advancing thetube and the annuloplasty structure includes transcatheterally advancingthe tube and the annuloplasty structure during a single transcatheteradvancement thereof.

60. The method according to inventive concept 58, further including:

advancing a first anchor through the lumen of the tube subsequently tosteering the tube toward the first location,

anchoring the annuloplasty structure at the first location thereof tothe annulus by advancing the first anchor through the annuloplastystructure and into tissue of the annulus,

advancing a second anchor through the lumen of the tube subsequently tosteering the tube toward the second location, and

anchoring the annuloplasty structure to the annulus at the secondlocation thereof by advancing the second anchor through the annuloplastystructure and into tissue of the annulus.

61. The method according to inventive concept 58, wherein theannuloplasty structure includes at least one elongate structure, andwherein advancing toward the valve the at least one annuloplastystructure includes advancing toward the valve the at least one elongatestructure.62. The method according to inventive concept 61, wherein advancingtoward the valve the at least one elongate structure includes advancingtoward the valve the at least one elongate structure in a substantiallylinear configuration thereof.63. The method according to inventive concept 62, further includingpulling the elongate structure into a curved configuration following theadvancing of the elongate structure toward the valve.64. The method according to inventive concept 62, further includingallowing the elongate structure to assume a curved configurationfollowing the advancing of the elongate structure toward the valve.65. A method for repairing a valve of a body of a patient, the valveincluding an annulus and at least first and second leaflets, including:

advancing a tube shaped to define a tube lumen toward the valve of thepatient;

advancing toward the valve at least one annuloplasty structurereversibly coupled to the tube and at respective locations thereof toone or more longitudinal guide members at respective distal portionsthereof, the one or more longitudinal guide members being disposed atleast in part along a distal portion of the tube;

positioning the annuloplasty structure against the annulus of thepatient; and

steering the distal portion of the tube toward a first location alongthe annuloplasty structure by pulling the one or more longitudinal guidemembers.

66. Apparatus, including:

a tubular structure having a lumen therein having a longitudinal axis;

a wire disposed at least in part within the lumen of the tubularstructure;

at least one elongate tube configured to be reversibly coupled at adistal portion thereof to the tubular structure; and

an extension coupled at a proximal portion thereof to the distal portionof the elongate tube, a distal portion of the extension being configuredto be disposed within the lumen of the tubular structure and to surroundat least a portion of the wire that is disposed at least in part withinthe lumen of the tubular structure.

67. The apparatus according to inventive concept 66, wherein the tubularstructure includes an annuloplasty structure.

68. The apparatus according to inventive concept 66, wherein the tubularstructure includes at least one subunit that is compressible along alongitudinal axis of the tubular structure.

69. The apparatus according to inventive concept 66, wherein the tubularstructure includes a braided mesh.

70. The apparatus according to inventive concept 66, wherein the tubularstructure includes at least one anchor mount having a longitudinal axisthereof that is transverse to the longitudinal axis of the tubularstructure, and wherein the anchor mount is shaped to provide at leastone first channel aligned along the longitudinal axis of the anchormount.71. The apparatus according to inventive concept 70, wherein the atleast a first channel includes first and second channels, wherein theanchor mount is shaped to provide the first channel in a vicinityadjacent to the second channel.72. The apparatus according to inventive concept 71, wherein the distalportion of the channel is configured to be disposed within the secondchannel.73. The apparatus according to inventive concept 71, wherein the distalportion of the elongate tube is configured to be disposed proximally tothe first channel of the anchor mount.74. The apparatus according to inventive concept 73, further includingat least one anchor configured to anchor the tubular structure to tissueof a patient, wherein the anchor is configured to be:

advanced toward the tubular structure via the elongate tube,

advanced through the first channel of the anchor mount, and

implanted within the tissue.

75. The apparatus according to inventive concept 66, further including aratchet mechanism configured to be disposed within the lumen of thetubular structure, the ratchet mechanism including a body portion, afirst end shaped to define at least one first engaging structure, and asecond end shaped to define at least one second engaging structureconfigured to engage the first engaging structure, wherein the ratchetmechanism is configured to maintain a ratcheted perimeter of the tubularstructure.76. The apparatus according to inventive concept 75, wherein:

the body portion is shaped to define at least one tubular body portionhaving at least one lumen therein,

the apparatus further includes a wire disposed at least in part withinthe lumen of the body portion, and

the tubular structure is configured to be advanced toward a left atriumof a patient in a generally straight configuration and subsequently toassume a curved configuration in response to a contracting force appliedthereto by contraction of the wire.

77. The apparatus according to inventive concept 75, wherein:

the body portion is shaped to define a flat body portion,

the apparatus further includes a wire disposed at least alongside thebody portion, and

the tubular structure is configured to be advanced toward a left atriumof a patient in a generally straight configuration and subsequently toassume a curved configuration in response to a contracting force appliedthereto by contraction of the wire.

78. Apparatus, including:

a tubular structure having a lumen thereof having a longitudinal axis;

at least one anchor mount coupled to the tubular structure, the anchormount being shaped to provide at least one channel having a longitudinalaxis that is at a non-zero angle with respect to the longitudinal axisof the tubular structure; and

a ratchet mechanism configured to be disposed within the lumen of thetubular structure, the ratchet mechanism including a body portion, afirst end shaped to define at least one first engaging structure, and asecond end shaped to define at least one second engaging structureconfigured to engage the first engaging structure, the ratchet mechanismconfigured to maintain a ratcheted perimeter of the tubular structure.

79. The apparatus according to inventive concept 78, wherein the tubularstructure includes a braided mesh.

80. The apparatus according to inventive concept 78, wherein the tubularstructure includes an annuloplasty structure.

81. The apparatus according to inventive concept 78, wherein the tubularstructure includes at least one subunit that is compressible along thelongitudinal axis of the tubular lumen.

82. The apparatus according to inventive concept 78, wherein the tubularstructure is configured for transcatheter advancement into an atrium ofa heart of a patient.

83. The apparatus according to inventive concept 78, wherein the tubularstructure includes a shape-memory alloy, the alloy being configured toassume a curved configuration once the structure has been advanced intoa left atrium of a patient.

84. The apparatus according to inventive concept 78, wherein the atleast one anchor mount includes two or more anchor mounts, and whereinthe tubular structure includes at least one subunit disposed between thetwo or more anchor mounts, the subunit being compressible along thelongitudinal axis of the tubular lumen.85. The apparatus according to inventive concept 78, wherein the anchormount is shaped to define an anchor mount lumen having a longitudinalaxis that is parallel with respect to the longitudinal axis of thetubular structure, and wherein the channel is disposed at the non-zeroangle with respect to the longitudinal axis of the anchor mount lumen.86. The apparatus according to inventive concept 85, wherein the ratchetmechanism is configured to be disposed within the lumen of the tubularstructure and within the anchor mount lumen.87. The apparatus according to inventive concept 86, further including awire disposed at least in part within the lumen of the tubular structureand within the anchor mount lumen.88. The apparatus according to inventive concept 86, wherein:

the body portion of the ratchet mechanism is shaped to define at leastone tubular body portion having at least one lumen therein,

the apparatus further includes a wire is disposed at least in partwithin the lumen of the body portion, and

the tubular structure is configured to be advanced toward an atrium of aheart of a patient in a generally straight configuration andsubsequently to assume a curved configuration in response to acontracting force applied thereto by contraction of the wire.

89. The apparatus according to inventive concept 86, wherein the tubularstructure includes at least one subunit that is compressible along alongitudinal axis of the tubular structure.

90. The apparatus according to inventive concept 86, wherein:

the body portion is shaped to define a flat body portion,

the wire is disposed at least alongside the body portion, and

the tubular structure is configured to be advanced toward an atrium of aheart of a patient in a generally straight configuration andsubsequently to assume a curved configuration in response to acontracting force applied thereto by contraction of the wire.

91. The apparatus according to inventive concept 86, wherein the anchormount lumen has a major axis that is (a) transverse with respect to thelongitudinal axis of the anchor mount lumen and (b) at a non-zero anglewith respect to the longitudinal axis of the first channel.92. The apparatus according to inventive concept 91, wherein:

the apparatus includes a plurality of anchor mounts,

each anchor mount of a first portion of the plurality of anchor mountshas a respective anchor mount lumen having a major axis that is disposedat a first angle with respect to the longitudinal axis of the channel,and

each anchor mount of a second portion of the plurality of anchor mountshas a respective anchor mount lumen having a major axis that is disposedat a second angle with respect to the longitudinal axis of the channel.

93. The apparatus according to inventive concept 78, further including awire disposed at least in part within the lumen of the tubularstructure, wherein the tubular structure is configured to be advancedtoward an atrium of a heart of a patient in a generally straightconfiguration and subsequently to assume a curved configuration inresponse to a contracting force applied thereto by contraction of thewire.94. The apparatus according to inventive concept 93, wherein the ratchetmechanism is configured to be advanced toward the atrium of the patientin a generally straight configuration and subsequently to assume acurved configuration in response to the contracting force.95. The apparatus according to inventive concept 93, wherein, inresponse to the contracting force, the wire is configured to drawtogether opposite ends of the ratchet mechanism and opposing ends of thetubular structure, and wherein the ratchet mechanism is configured tomaintain respective first ratcheted perimeters of the tubular structureand the ratchet mechanism.96. The apparatus according to inventive concept 95, wherein, inresponse to an additional contracting force by additional contraction ofthe wire, the wire is configured to contract the ratchet mechanism andthe tubular structure to respective second ratcheted perimeters thereof,each second ratcheted perimeter being smaller than the respective firstratcheted perimeters, and wherein the ratchet mechanism is configured tomaintain the respective second ratcheted perimeters of the ratchetmechanism and the tubular structure.97. The apparatus according to inventive concept 78, further including aplurality of longitudinal guide members, wherein each guide member isremovably coupled to the tubular element and is configured to facilitateanchoring of the tubular structure to the annulus of the patient.98. The apparatus according to inventive concept 97, wherein a distalend of the longitudinal guide member is coupled to the tubular elementin a vicinity of the anchor mount.99. The apparatus according to inventive concept 97, further including abar configured to be disposed within the channel.100. The apparatus according to inventive concept 99, further includingat least one anchor configured to be guided toward the anchor mount viathe longitudinal guide member and advanced through the channel of theanchor mount, around the bar, and into tissue of an annulus of thepatient.101. The apparatus according to inventive concept 100, wherein thelongitudinal guide member is configured to be looped around the bar andto be decoupled from the bar following the advancement of the anchorinto the annulus.102. The apparatus according to inventive concept 99, wherein the bar isdisposed within the channel angularly with respect to an axis of thechannel.103. The apparatus according to inventive concept 102, wherein the baris disposed within the channel substantially parallel to thelongitudinal axis of the tubular lumen.104. The apparatus according to inventive concept 97, wherein the atleast one anchor mount includes two or more anchor mounts, and whereinthe at least one longitudinal guide member includes two or morelongitudinal guide members having respective distal ends thereofconfigured to be reversibly coupled to the tubular structure.105. The apparatus according to inventive concept 104, wherein each onethe two or more anchor mounts has a longitudinal axis thereof that istransverse to the longitudinal axis of the tubular structure, andwherein each mount shaped to provide a channel aligned along thelongitudinal axis of the respective anchor mount.106. The apparatus according to inventive concept 105, wherein:

the apparatus further includes an elongate tube shaped to define anelongate tube lumen, the elongate tube being configured to be coupled tothe tubular structure, and

the two or more longitudinal guide members are aligned in parallel withthe elongate tube and coupled to a distal portion of the tube, thelongitudinal guide members having distal ends thereof configured to bereversibly coupled to the tubular structure, and arranged in a manner inwhich:

-   -   application of a force to a first one of the longitudinal guide        members steers the distal portion of the elongate tube toward a        first location along the tubular structure, and    -   application of a force to a second one of the longitudinal guide        members steers the distal portion of the elongate tube toward a        second location along the tubular structure.        107. The apparatus according to inventive concept 106, wherein:

the first location includes a second one of the two or more anchormounts,

the second location includes a second one of the two or more anchormounts,

a respective one of the two or more longitudinal guide members isreversibly coupled to each of the two or more anchor mounts, and

application of the force to the first one of the longitudinal guidemembers steers the distal portion of the elongate tube toward the firstanchor mount, and application of the force to the second one of thelongitudinal guide members steers the distal portion of the elongatetube toward the second anchor mount.

108. The apparatus according to inventive concept 107, further includingat least one anchor configured to be advanced through the lumen of theelongate tube, wherein the anchor is configured to be advanced throughthe channel of a first one of the two or more anchor mounts in responseto steering the distal portion of the elongate tube toward the anchormount by applying the force to the first one of the longitudinal guidemembers.109. Apparatus, including:

a tubular structure having a lumen therein having a longitudinal axis;

a wire disposed in part within the lumen of the tubular structure, thewire having first and second portions thereof, the first and secondportions of the wire being disposed externally to the lumen of thetubular structure; and

a handle assembly including at least one rotating element configured tobe coupled to the first and second ends of the wire, in a manner inwhich rotation of the rotating element applies a force to the wiredisposed within the tubular structure and adjusts a perimeter of thetubular structure.

110. The apparatus according to inventive concept 109, wherein thetubular structure includes an annuloplasty structure.

111. The apparatus according to inventive concept 109, wherein thetubular structure includes at least one subunit that is compressiblealong a longitudinal axis of the tubular structure.

112. The apparatus according to inventive concept 109, wherein thetubular structure includes at least one anchor mount coupled to thetubular structure, the anchor mount having a longitudinal axis that istransverse to the longitudinal axis of the tubular structure and shapedto provide a channel aligned along the longitudinal axis of the anchormount.113. The apparatus according to inventive concept 109, wherein thetubular structure includes a braided mesh.114. The apparatus according to inventive concept 109, wherein:

in response to a rotation of the rotating element, the wire isconfigured to contract the tubular structure to a first perimeterthereof, and

in response to an additional rotation of the rotating element, the wireis configured to contract the tubular structure to a second perimeterthereof, the second perimeter being smaller than the first perimeter.

115. The apparatus according to inventive concept 109, further includinga ratchet mechanism configured to be disposed within the lumen of thetubular structure, the ratchet mechanism including a body portion, afirst end shaped to define at least one first engaging structure, and asecond end shaped to define at least one second engaging structureconfigured to engage the first engaging structure, wherein the ratchetmechanism is configured to maintain a ratcheted perimeter of the tubularstructure.116. The apparatus according to inventive concept 115, wherein:

in response to a first contracting force by contraction of the wire, thewire is configured to contract the ratchet mechanism and the tubularstructure to respective first ratcheted perimeters thereof,

in response to a second contracting force by additional contraction ofthe wire, the wire is configured to contract the ratchet mechanism andthe tubular structure to respective second ratcheted perimeters thereof,each second ratcheted perimeter being smaller than the respective firstratcheted perimeters, and

the ratchet mechanism is configured to maintain the respective secondratcheted perimeters of the ratchet mechanism and the tubular structure.

117. The apparatus according to inventive concept 115, wherein:

the body portion is shaped to define at least one tubular body portionhaving at least one lumen therein,

the wire is disposed at least in part within the lumen of the bodyportion, and

the tubular structure is configured to be advanced toward a left atriumof a patient in a generally straight configuration and subsequently toassume a curved configuration in response to a contracting force appliedthereto by contraction of the wire.

118. The apparatus according to inventive concept 115, wherein:

the body portion is shaped to define a flat body portion,

the wire is disposed at least alongside the body portion, and

the tubular structure is configured to be advanced toward a left atriumof a patient in a generally straight configuration and subsequently toassume a curved configuration in response to a contracting force appliedthereto by contraction of the wire.

119. Apparatus for use with tissue of a patient, including:

a housing having a lateral wall having a proximal and a distal portion,the lateral wall being shaped to define a channel extending from a firstopening in the proximal portion to a second opening in the distalportion, the channel having a longitudinal axis thereof; and

an anchor structure configured for passage through the channel and intothe tissue, including:

-   -   a plurality of coils; and    -   a head portion defining a diameter of the structure that is        larger than a diameter of the first opening, the head portion        configured to:        -   restrict distal motion of the plurality of coils beyond a            predetermined depth by abutting against the first opening of            the proximal portion, and        -   draw tissue proximally by rotation of the head portion            around the longitudinal axis of the channel.            120. Apparatus, including:

a tubular implant shaped to define an implant lumen;

a flexible longitudinal member disposed within the implant lumen, theflexible longitudinal member having a first end that is slidable withrespect to a second end thereof to form the longitudinal member into aclosed loop having a perimeter thereof which (a) shortens when the firstend is advanced in a first direction with respect to the second end in afirst direction, and (b) expands when the first end is advanced withrespect to the second end in a second direction opposite to the firstdirection; and

a flexible contracting member being disposed alongside the longitudinalmember and within and slidably advanceable through the implant lumen tofacilitate reduction of the perimeter of the longitudinal member byapplication of a compression force to the longitudinal member.

121. The apparatus according to inventive concept 120, wherein thecontracting wire facilitates sliding of the first end of the flexiblemember with respect to the second end in the second direction, even inthe absence of a force applied to the contracting wire.122. The apparatus according to inventive concept 120, wherein, inresponse to a pulling force applied to the contracting member, theflexible member is configured to facilitate compression of the implant,and responsively to the compression of the implant, to facilitatesliding of the first end of the longitudinal member with respect to thesecond end in the first direction.123. The apparatus according to inventive concept 120, wherein:

when formed into the closed loop, the longitudinal member is shaped toprovide an inner surface and an outer surface with respect to a centerof the closed loop,

the flexible contracting member is disposed alongside the longitudinalmember externally to the outer surface thereof, and

in response to the pulling force applied to the contracting wire, thecontracting wire is configured to facilitate sliding of the first end ofthe longitudinal member with respect to the second end in the firstdirection.

124. A method, including:

providing:

-   -   a tubular implant having an implant lumen,    -   a flexible longitudinal member disposed within the implant        lumen, the flexible longitudinal member having a first end that        is slidable with respect to a second end thereof, and    -   a flexible contracting member being disposed alongside the        longitudinal member and within and slidably advanceable through        the implant lumen, the flexible longitudinal member having a        first end that is slidable with respect to a second end thereof        to form the longitudinal member into a closed loop having a        perimeter thereof which (a) shortens when the first end is        advanced in a first direction with respect to the second end in        a first direction, and (b) expands when the first end is        advanced with respect to the second end in a second direction        opposite to the first direction; and

reducing the perimeter of the longitudinal member by applying acompression force to the longitudinal member.

125. The method according to inventive concept 124, further comprisingfacilitates sliding of the first end of the flexible member with respectto the second end in the second direction, even in the absence of aforce applied to the contracting wire.

126. The method according to inventive concept 124, further comprisingapplying a pulling force to the contracting member, and wherein applyingthe compression force to the longitudinal member comprises:

responsively to the applying the pulling force to the contractingmember, compressing the implant, and

responsively to the compressing the implant:

-   -   applying the compression force to the longitudinal member,    -   facilitating sliding of the first end of the longitudinal member        with respect to the second end in the first direction, and    -   compressing the longitudinal member.        127. The method according to inventive concept 124, wherein:

the method further comprises forming the longitudinal member into theclosed loop wherein the flexible member has an inner surface and anouter surface with respect to a center of the closed loop, and theflexible contracting member is disposed alongside the longitudinalmember externally to the outer surface thereof, and

reducing the perimeter of the longitudinal member comprises:

-   -   applying a pulling force to the contracting wire, and    -   responsively to the applying the pulling force, facilitating        sliding of the first end of the longitudinal member with respect        to the second end in the first direction.

There is therefore provided, in accordance with an embodiment of thepresent invention, apparatus for repairing a valve of a body of apatient, the valve including an annulus and at least first and secondleaflets, including:

at least a first discrete segment and a second discrete segment of anannuloplasty structure, each segment being shaped to provide arespective lateral wall, each lateral wall being shaped to define atleast one lumen of the respective segment; and

at least a first and a second control wire, each control wire configuredfor sliding advancement through both the first and second segments:

-   -   the first control wire is configured to control a relative        disposition of a first end of the first segment and a first end        of the second segment, and    -   the second control wire is configured to control a relative        disposition of a second end of the first segment and a second        end of the second segment.

In an embodiment, the first and second segments are configured fortranscatheter advancement into a left atrium of a patient.

In an embodiment, the first and second segments are configured forsimultaneous advancement toward a left atrium of a patient.

In an embodiment, for each lateral wall of each segment, the lateralwall has a first and a second portion, and the segment is shaped toprovide a channel extending from the first portion to the secondportion.

In an embodiment, the apparatus includes a bar configured to be disposedwithin the channel.

In an embodiment, the bar is disposed within the channel substantiallyperpendicular to an axis of the channel.

In an embodiment, the apparatus includes a flexible longitudinal guidemember configured to be removably coupled to the bar.

In an embodiment, the apparatus includes an anchoring structure, andwhile the guide member is disposed within the body of the patient, theanchoring structure is configured to be advanced via the guide member,through the channel, and subsequently anchored to the annulus of thepatient.

In an embodiment, the anchoring structure includes a pointed distal tip.

In an embodiment, while the guide member is disposed within the body ofthe patient, the anchoring structure is configured to be advanced alongthe guide member from a site outside the body of the patient.

In an embodiment, while the guide member is disposed within the body ofthe patient, the guide member is configured to be decoupled from the barsubsequent to the anchoring of the anchoring structure to the annulus.

In an embodiment, the anchoring structure includes a helical element ata distal end thereof, the helical element shaped to provide a proximalend of the helical element and a distal end of the helical element.

In an embodiment, the apparatus includes an advancement tube having adistal tip thereof, at least a portion of the proximal end of thehelical element is configured to be coupled to the distal tip of theadvancement tube.

In an embodiment, the helical element is shaped to define a first numberof proximal rotational subunits and a second number of distal rotationalsubunits, and the proximal rotational subunits are wrapped around thedistal tip of the advancement tube.

In an embodiment, the proximal rotational subunits are coupled to thedistal tip of the advancement tube by a first frictional force.

In an embodiment, the second number is greater than the first number.

In an embodiment, the advancement tube is configured to be rotated and,in response to the rotation, the distal rotational subunits areconfigured to be implanted within the annulus of the patient.

In an embodiment, at least a portion of the distal tip is shaped todefine a protrusion disposed adjacent to the proximal end of the helicalelement, the protrusion being configured to apply acircumferentially-directed force to the proximal end of the helicalelement as the advancement tube is rotated.

In an embodiment, during the rotation of the advancement tube:

the proximal rotational subunits are configured to slide distally alongthe distal tip of the advancement tube, and

in response to the sliding, a portion of the first number of proximalrotational subunits remains wrapped around the distal tip of theadvancement tube.

In an embodiment, a number of proximal rotational subunits in theportion is less than the first number of proximal rotational subunits.

In an embodiment, the portion of the proximal rotational subunits iscoupled to the distal tip of the advancement tube by a second frictionalforce, the second frictional force being weaker than the firstfrictional force.

In an embodiment, the second frictional force being weaker than thefirst frictional force facilitates decoupling of the distal tip of theadvancement tube from the helical element.

In an embodiment:

the helical element is shaped to define at least two adjacent distalrotational subunits and at least two adjacent proximal rotationalsubunits, and

a distance between the two adjacent distal rotational subunits isgreater than a distance between the two adjacent proximal rotationalsubunits.

In an embodiment, the distance between the distal rotational subunitsenables the distal rotational subunits to be corkscrewed around the barand subsequently into the annulus of the patient.

In an embodiment, the distance between the proximal rotational subunitsrestricts the proximal rotational subunits from being corkscrewed aroundthe bar and into the annulus of the patient.

In an embodiment, the first and second segments are configured to beadvanced toward a left atrium of the patient in a generally straightconfiguration and subsequently are made to assume a curvedconfiguration.

In an embodiment, the first and second control wires are configured topull the first and second segments into curved configurations.

In an embodiment, the first and second segments include a shape-memoryalloy, the alloy being configured to assume a curved configuration oncethe segments have been advanced into the left atrium of the patient.

In an embodiment, the apparatus includes at least first and secondflexible longitudinal guide members, the first and second guide membersconfigured to be removably coupled to the first and second segments,respectively, each guide member being configured to facilitate anchoringof the respective segment to the annulus of the patient.

In an embodiment, the apparatus includes respective at least first andsecond anchoring structures, the first and second anchoring structuresconfigured to be disposed at respective distal ends of the first andsecond guide members, respectively, the anchoring structures beingconfigured to be screwed into the annulus of the patient in response toa rotational force applied to a respective proximal end of therespective guide members.

In an embodiment, each of the anchoring structures includes a pointeddistal tip.

In an embodiment, the first and second control wires are configured tocontrol a relative disposition of the first and second segments.

In an embodiment, the first and second control wires are configured toseparate the first and second segments.

In an embodiment, the first and second control wires are configured tofacilitate positioning of the first and second segments along theannulus.

In an embodiment, the first and second segments are configured to beadvanced toward a left atrium of the patient in a generally straightconfiguration thereof, and the first and second control wires areconfigured to pull the first and second segments into a curvedconfiguration.

In an embodiment,

the first and second segments are configured to be advanced toward anatrium of a heart of the patient in a generally straight configuration,the straight configuration defining a longitudinal axis of therespective first and second segments,

at least a portion of the first and second segments is shaped to defineone or more compressible units, and

the compressible units are configured to be compressed in parallel withthe longitudinal axis of the respective segments.

In an embodiment, the compressible units are configured to be compressedin response to an application of a pulling force to the first and secondcontrol wires.

In an embodiment, the first control wire is configured to compress thefirst segment at least in part in response to an application of apulling force to at least a portion of the first control wire, and thesecond control wire is configured to compress the second segment atleast in part in response to an application of a pulling force to atleast a portion of the second control wire.

In an embodiment, the apparatus includes first and second adjustmentwires, coupled to the first and second control wires, respectively, thefirst adjustment wire is coupled to the first control wire at a firstjunction between the first and second segments, and the secondadjustment wire is coupled to the second control wire at a secondjunction between the first and second segments.

In an embodiment, the adjustment wires are configured to facilitatealigning of the first and second segments with the annulus by separatingthe segments.

In an embodiment, the adjustment wires are configured to facilitatealigning of the first and second segments with the annulus by elevatingportions of the first and second segments.

There is further provided, in accordance with an embodiment of thepresent invention apparatus for repairing a valve of a body of apatient, the valve including an annulus and at least first and secondleaflets, including:

an annuloplasty structure,

-   -   shaped to provide one or more channels, each channel extending        from a respective first portion of a lateral wall of the        annuloplasty structure to a respective second portion of the        lateral wall of the annuloplasty structure, and    -   including one or more bars, each bar configured to be disposed        within a respective one of the channels; and

one or more flexible longitudinal guide members, each guide memberconfigured to be removably coupled to a respective one of the bars.

In an embodiment, each guide member is removably coupled to therespective bar by being looped around the respective bar.

In an embodiment, the annuloplasty structure includes an annuloplastyring.

In an embodiment, the annuloplasty structure includes a partialannuloplasty ring.

In an embodiment, the structure and the one or more guide members areconfigured to be transcatheterally advanced into a left atrium of thepatient.

In an embodiment, the structure and the one or more guide members areconfigured to be simultaneously advanced toward a left atrium of thepatient.

In an embodiment, the annuloplasty structure includes two or moresegments of an annuloplasty ring.

In an embodiment, each bar is disposed within a respective one of thechannels substantially perpendicular to an axis of the channel.

In an embodiment, the structure includes a shape-memory alloy.

In an embodiment, the structure is configured to be advanced toward aleft atrium of the patient in a generally straight configuration andsubsequently to be made to assume a curved configuration.

In an embodiment, the apparatus includes at least one control wire, andthe control wire is configured to pull the structure into the curvedconfiguration.

In an embodiment, the structure includes a shape-memory alloy, the alloybeing configured to assume a curved configuration once the structure hasbeen advanced into the left atrium of the patient.

In an embodiment, the apparatus includes at least one control wire incommunication with the structure configured to adjust a disposition ofthe structure.

In an embodiment, the lateral wall of the annuloplasty structure isshaped to define at least one lumen of the structure.

In an embodiment, the at least one control wire is configured forsliding advancement through the at least one lumen, and to control fromwithin the lumen a conformation of the structure.

In an embodiment,

the structure is configured to be advanced toward a left atrium of thepatient in a generally straight configuration, the straightconfiguration defining a longitudinal axis thereof,

at least a portion of the structure is shaped to define one or morecompressible units, and

the compressible units are configured to be compressed in parallel withthe longitudinal axis.

In an embodiment, the compressible units are configured to be compressedin response to an application of a pulling force to the at least onecontrol wire.

In an embodiment, the structure includes a first and a second segment,the first and second segments each shaped to provide a respectivelateral wall, each lateral wall being shaped to define at least onerespective lumen of the respective segment.

In an embodiment, the apparatus includes at least one adjustment wirecoupled to the at least one control wire, and the at least oneadjustment wire is configured to be coupled to the at least one controlwire at a junction between the first and second segments.

In an embodiment, the at least one adjustment wire is configured tofacilitate aligning of the first and second segments with the annulus byseparating the segments.

In an embodiment, the at least one adjustment wire is configured tofacilitate aligning of the first and second segments with the annulus byelevating portions of at least one of the segments.

In an embodiment, the control wire is configured for sliding advancementthrough the at least one lumen of each of the first and second segments.

In an embodiment, the at least one control wire includes a first and asecond control wire.

In an embodiment:

the first and second segments are each shaped to provide respectivefirst and second lumens, and

the first control wire is configured for sliding advancement througheach of the first lumens, and the second control wire is configured forsliding advancement through each of the second lumens.

In an embodiment, the first and second control wires are configured tocontrol a relative disposition of the first and second segments.

In an embodiment, the first and second control wires are configured toseparate portions of the first and second segments.

In an embodiment, the first and second control wires are configured tofacilitate positioning of the first and second segments along theannulus.

In an embodiment, the first and second segments are configured to beadvanced toward a left atrium of the patient in a generally straightconfiguration thereof, and the first and second control wires areconfigured to pull the first and second segments into a curvedconfiguration.

In an embodiment,

the first and second segments are configured to be advanced toward aleft atrium of the patient in a generally straight configuration, thestraight configuration defining a longitudinal axis of the respectivefirst and second segments,

at least a portion of each of the first and second segments is shaped todefine one or more compressible units, and

the compressible units are configured to be compressed in parallel withthe longitudinal axis of the respective segments.

In an embodiment, the compressible units are configured to be compressedin response to an application of a pulling force to the first and secondcontrol wires.

In an embodiment:

the first control wire is configured to compress the first segment atleast in part in response to an application of a pulling force to atleast a portion of the first control wire, and

the second control wire is configured to compress the second segment atleast in part in response to an application of a pulling force to atleast a portion of the second control wire.

In an embodiment, the apparatus includes one or more anchoringstructures, each anchoring structure configured to be advanced through arespective one of the channels and subsequently anchored to the annulusof the patient.

In an embodiment, the anchoring structure is shaped to define a pointeddistal tip.

In an embodiment, while the guide member is disposed within the body ofthe patient, each anchoring structure is configured to be advanced alonga respective one of the guide members from a site outside the body ofthe patient.

In an embodiment, the guide member is configured to be decoupled fromthe bar subsequent to the anchoring of the anchoring structure to theannulus.

In an embodiment, each of the anchoring structures includes a helicalelement at a distal end thereof.

In an embodiment:

the helical element is shaped to define at least two adjacent distalrotational subunits and at least two adjacent proximal rotationalsubunits, and

a distance between the two adjacent distal rotational subunits isgreater than a distance between the two adjacent proximal rotationalsubunits.

In an embodiment, the distance between the distal rotational subunitsenables the distal rotational subunits to be corkscrewed around the barand subsequently into the annulus of the patient.

In an embodiment, the distance between the proximal rotational subunitsrestricts the proximal rotational subunits from being corkscrewed fullyaround the bar and into the annulus of the patient.

There is yet further provided, in accordance with an embodiment of thepresent invention apparatus for repairing a valve of a body of apatient, the valve including an annulus and at least first and secondleaflets, including:

an annuloplasty structure including a bar; and

an anchoring structure including a helical element, the helical elementshaped to define at least two adjacent distal rotational subunits and atleast two adjacent proximal rotational subunits, a distance between thetwo adjacent distal rotational subunits is greater than a distancebetween the two adjacent proximal rotational subunits, and:

the distance between the distal rotational subunits enables the distalrotational subunits to be corkscrewed around the bar and subsequentlyinto tissue of a patient, and

the distance between the proximal rotational subunits restricts theproximal rotational subunits from being corkscrewed into tissue of thepatient.

In an embodiment, the annuloplasty structure includes an annuloplastyring.

In an embodiment, the annuloplasty structure includes a partialannuloplasty ring.

In an embodiment, the annuloplasty structure includes two or moresegments of an annuloplasty ring.

In an embodiment, the apparatus includes a flexible longitudinal guidemember reversibly coupled to the structure, and configured to facilitateanchoring of the annuloplasty structure to the annulus of the patient.

In an embodiment,

the annuloplasty structure is shaped to provide a lateral wall having atleast first and second portions, and shaped to provide at least onechannel,

the at least one channel extends from the first portion of the lateralwall of the structure to the second portion of the lateral wall of thestructure,

the bar is disposed within the at least one channel substantiallyperpendicular to an axis of the channel, and

the guide member is reversibly coupled to the bar.

In an embodiment, the anchoring structure is disposed at a distal end ofthe guide member.

In an embodiment, the anchoring structure is configured to be screwedinto the annulus in response to a rotational force applied to a proximalend of the guide member.

In an embodiment, the apparatus includes a hollow tube configured to bereversibly coupled to the helical element, and to push the anchoringstructure toward the annuloplasty structure.

In an embodiment, the hollow tube is configured to be advanced aroundthe guide member while the guide member is disposed within the body ofthe patient.

In an embodiment, the helical element is disposed around the hollowtube, the hollow tube is configured to be rotated at a proximal portionthereof, and the anchoring structure is corkscrewed into the annulus ofthe patient in response to the rotation of the tube.

In an embodiment, a diameter of the bar is greater than the distancebetween the proximal rotational subunits, and during an attempt tocorkscrew the proximal rotational subunits therearound:

the bar restricts the proximal rotational subunits from beingcorkscrewed into tissue of the patient by applying a counterforce to atorque applied by the rotation of the tube, and

the proximal rotational subunits are configured to expand radially inresponse to the counterforce applied by the bar.

In an embodiment, the helical element is configured to be detached fromthe hollow tube in response to the radial expansion of the proximalrotational subunits.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method for performing an annuloplasty on a valve ofa body of a patient the valve including an annulus and at least firstand second leaflets, including:

deploying an annuloplasty structure in an atrium of a heart of thepatient, the structure including one or more bars and one or morerespective flexible longitudinal guide members, each guide memberreversibly coupled to a respective one of the bars;

positioning the annuloplasty structure along the annulus of the valve ofthe patient;

advancing one or more respective anchoring structures, each anchoringstructure each anchoring structure being passed along a respective oneof the flexible longitudinal guide members while the one or more guidemembers are disposed within the body of the patient;

advancing at least a portion of each anchoring structure beyond therespective bar and into tissue of the patient; and

decoupling each guide member from the respective bar.

In an embodiment, deploying the annuloplasty structure includes placingthe annuloplasty structure in the atrium during an open heart procedure.

In an embodiment, deploying the annuloplasty structure includesdeploying at least one segment of an annuloplasty ring.

In an embodiment, deploying the annuloplasty structure includesdeploying an annuloplasty ring.

In an embodiment, deploying the annuloplasty structure includesdeploying a partial annuloplasty ring.

In an embodiment, the method includes advancing the annuloplastystructure to the atrium transcatheterally.

In an embodiment, the method includes performing, during a singletranscatheter advancement, the steps of: (a) deploying the annuloplastystructure, (b) positioning the annuloplasty structure, (c) advancing theone or more respective anchoring structures, (d) advancing the at leasta portion of each anchoring structure, and (e) decoupling each guidemember.

In an embodiment, positioning the annuloplasty structure includesadjusting a configuration of the annuloplasty structure with respect toa configuration of the annulus of the patient.

In an embodiment, the annuloplasty structure is generally ring-shapedfollowing the deployment, thereby defining a radius characteristicthereof, and adjusting the configuration of the structure includesreducing the radius by compressing at least a portion of the structure.

In an embodiment, compressing includes applying a pulling force to acontrol wire disposed within a lumen of the structure.

In an embodiment, deploying the structure includes deploying twosegments of the annuloplasty ring.

In an embodiment, the method includes drawing together the first andsecond segments.

In an embodiment, positioning the structure along the annulus of thepatient includes positioning the first and second segments along theannulus.

In an embodiment, positioning the first and second segments includespositioning the first segment on the annulus along a junction between abase of a first leaflet and the annulus, and positioning the secondsegment on the annulus along a junction between a base of a secondleaflet and the annulus.

In an embodiment, positioning the first and second segments includesadjusting a relative disposition of the first and second segments withrespect to a configuration of the annulus of the patient.

In an embodiment, adjusting the disposition of the first and secondsegments includes elevating at least a portion of the first segment andat least a portion of the second segment.

In an embodiment, adjusting the first and second segments includesadjusting the first segment independently of the adjusting of the secondsegment.

In an embodiment, the annuloplasty structure is configured to assume agenerally straight configuration following the deployment, the straightconfiguration defining a longitudinal axis of the structure, andadjusting the disposition of the first and second segments includesadjusting a disposition of the first and second segments by compressingin parallel with the longitudinal axis of the structure at least aportion of the first segment and at least a portion of the secondsegment.

In an embodiment, compressing includes applying a pulling force to atleast one control wire disposed within a lumen of each of the first andsecond segments.

There is also provided, in accordance with an embodiment of the presentinvention, apparatus for repairing a valve of a body of a patient, thevalve including an annulus and at least first and second leaflets,including:

an annuloplasty structure; and

a flexible longitudinal guide member removably coupled to the structure:

-   -   the guide member is configured to facilitate anchoring of the        annuloplasty structure to the annulus of the patient, and    -   the guide member is configured to be advanced toward the annulus        simultaneously with the annuloplasty structure.

In an embodiment, the annuloplasty structure includes an annuloplastyring.

In an embodiment, the annuloplasty structure includes a partialannuloplasty ring.

In an embodiment, the annuloplasty structure includes at least first andsecond segments of an annuloplasty ring.

In an embodiment, the apparatus includes an anchoring structureconfigured to anchor the structure to the annulus via the guide member.

In an embodiment, the anchoring structure includes a pointed distal tip.

In an embodiment, of the anchoring structure is disposed at a distal endof the guide member, and is configured to be screwed into the annulus inresponse to a rotational force applied to a proximal end of the guidemember.

In an embodiment, the annuloplasty structure is shaped to define alateral wall having first and second portions, and to provide a channelextending from the first portion of the lateral wall to the secondportion of the lateral wall of the structure.

In an embodiment, the anchoring structure is configured to be advancedthrough the channel and subsequently anchored to the annulus of thepatient while the one or more guide members are disposed within the bodyof the patient.

In an embodiment, the apparatus includes a bar configured to be disposedwithin the channel.

In an embodiment, the bar is disposed within the channel substantiallyperpendicular to an axis of the channel.

In an embodiment, the guide member is configured to be removably coupledto the bar.

In an embodiment, the anchoring structure is configured to be advancedalong the guide member from a site outside the body of the patient whilethe guide member is disposed within the body of the patient.

In an embodiment, the guide member is configured to be decoupled fromthe bar subsequent to the anchoring of the anchoring structure to theannulus.

In an embodiment, the anchoring structure includes a helical element ata distal end thereof, the helical element being configured to becorkscrewed at least in part into the annulus of the patient.

In an embodiment, the helical element is shaped to define at least twoadjacent distal rotational subunits and at least two adjacent proximalrotational subunits, and a distance between the two adjacent distalrotational subunits is greater than a distance between the two adjacentproximal rotational subunits.

In an embodiment, the distance between the distal rotational subunitsenables the distal rotational subunits to be corkscrewed around the barand subsequently into the annulus of the patient.

In an embodiment, the distance between the proximal rotational subunitsrestricts the proximal rotational subunits from being corkscrewed aroundthe bar and into the annulus of the patient.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an annuloplasty structurecomprising a ratchet mechanism, in accordance with an embodiment of thepresent invention;

FIGS. 2A-B are schematic illustrations of a ratchet mechanisms for usewith an annuloplasty structure, in accordance with respectiveembodiments of the present invention;

FIG. 3 is a schematic illustration of the ratchet mechanism of FIG. 2Acoupled to an anchor mount, in accordance with an embodiment of thepresent invention;

FIG. 4 is a schematic illustration of an anchor coupled to the anchormount of FIG. 3, in accordance with an embodiment of the presentinvention;

FIGS. 5A-C are schematic illustrations of the ratchet mechanism of FIG.2A coupled to an anchor mount, in accordance with another embodiment ofthe present invention;

FIGS. 6A-B and 7 are schematic illustrations of a ratchet mechanism foruse with an annuloplasty structure, in accordance with respectiveembodiments of the present invention;

FIGS. 8-10 are schematic illustrations of a mount for use in anchoringan annuloplasty structure to the annulus of the patient, in accordancewith respective embodiments of the present invention;

FIG. 11 is a schematic illustration of a channel for use in combinationwith an annuloplasty structure and for passage therethrough of an anchorin order to anchor the annuloplasty structure to the annulus of thepatient, in accordance with an embodiment of the present invention;

FIGS. 12, 13A-E, 14A-B, and 15 are schematic illustrations of anchorsfor anchoring an annuloplasty structure to the annulus of the patient,in accordance with respective embodiments of the present invention;

FIGS. 16A-B are schematic illustrations of an anchor advancementstructure, in accordance with an embodiment of the present invention;

FIGS. 17A-J are schematic illustrations of transcatheter advancement anddeploying of a system for repairing an annulus of the patient, inaccordance with an embodiment of the present invention;

FIGS. 18A-B are schematic illustrations of the deployment of twoannuloplasty ring segments of the system toward the annulus of thepatient, in accordance with an embodiment of the present invention;

FIGS. 19A-E are schematic illustrations of an anchoring apparatuscomprising a steerable catheter configured to facilitate anchoring ofthe two annuloplasty ring segments to the annulus of the patient, inaccordance with an embodiment of the present invention;

FIGS. 20A-B are schematic illustrations of the anchoring apparatusconfigured to anchor the two annuloplasty ring segments to the annulusof the patient, in accordance with an embodiment of the presentinvention;

FIGS. 21-22 are schematic illustrations of a handle for anchoring anannuloplasty structure to the annulus of the patient, in accordance withan embodiment of the present invention;

FIGS. 23A-B are schematic illustrations of an annuloplasty structurecomprising a ratchet mechanism, in accordance with still yet anotherembodiment of the present invention;

FIGS. 24A-J are schematic illustrations of transcatheter advancement anddeploying of a system for repairing an annulus of the patient, inaccordance with an embodiment of the present invention;

FIGS. 25A-F are schematic illustrations of the deployment of twoannuloplasty ring segments of the system toward the annulus of thepatient, in accordance with an embodiment of the present invention;

FIGS. 26A-B, 27A-E, and 28A-B are schematic illustrations of anchoringapparatus configured to anchor the two annuloplasty ring segments to theannulus of the patient, in accordance with an embodiment of the presentinvention; and

FIGS. 28C-D are schematic illustrations of the drawing together andlocking of the two segments of the annuloplasty ring to the annulus ofthe patient, in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Reference is now made to FIG. 1, which is a schematic illustration of anannuloplasty structure 100, e.g., at least one elongate segment ortubular element, comprising a plurality of compressible subunits 450 anda plurality of anchor mounts 461, in accordance with an embodiment ofthe present invention. Structure 100 comprises a modular annuloplastystructure in which the plurality of compressible subunits 450 arealternately disposed with respect to the plurality of anchor mounts 461.Typically, structure 100 comprises an implant shaped to define a tubularstructure having a cross-section of any suitable shape, e.g., circularor elliptical. Compressible subunits 450 are shaped to define a hollowlumen and comprise a braided mesh 452 (e.g., wire or polyester), by wayof illustration and not limitation. For example, compressible subunits450 may comprise a plurality of coils, braided structures, stent-shapedstruts, or accordion- or bellows-shaped structures. A ratchet mechanism600 (described hereinbelow with reference to FIGS. 6A-B) is disposedwithin the hollow lumen of structure 100. Ratchet mechanism 600comprises a ratchet body 202 having a fixed end 210 and a dynamic end220. Although ratchet mechanism 600 is shown as being used incombination with structure 100, it is to be noted that any of theratchet mechanisms described herein may be used in combination withstructure 100.

Typically compressible subunits 450 and anchor mounts 461 comprise abiocompatible material, e.g., nitinol, ePTFE, PTFE, stainless steel,platinum iridium, titanium, or cobalt chrome. In some embodiments,compressible subunits 450 and anchor mounts 461 are coated with PTFE(Polytetrafluoroethylene). In some embodiments, compressible subunits450 function as accordion- or bellows-shaped compressible structureswhich facilitate proper cinching of the annulus when structure 100 iscontracted. The configuration of the annulus of the mitral valve differsfrom patient to patient. Compressible subunits 450, when compressed,e.g., typically along a longitudinal axis of structure 100, enablerespective portions of annuloplasty structure 100 to independentlyconform to the configuration of each portion of the annulus that is inalignment with a given portion of the annuloplasty structure.

It is to be noted that for some applications, annuloplasty structure 100is shaped to define a single tubular structure independently of theplurality of anchor mounts 461. In such an embodiment, the singletubular structure comprises an elongate sheath of compressible material,as described hereinabove with respect to compressible subunits 450.

A contracting wire (not shown) is disposed within the lumen of structure100 generally alongside ratchet body 202. Typically, pulling on thecontracting wire controls the structural configuration of ratchet body202 which in turn controls the structural configuration of structure100, as will be described hereinbelow. In response to the pulling of thewire, an inward radial force is applied to structure 100, and aperimeter of structure 100 is modulated, i.e., reduced.

The contracting wire comprises a flexible and/or superelastic material,e.g., nitinol, polyester, PTFE, ePTFE, stainless steel, or cobaltchrome, and is configured to reside chronically within structure 100. Insome embodiments, the contracting wire comprises a braided polyestersuture (e.g., Ticron). In some embodiments, the contracting wire iscoated with polytetrafluoroethylene (PTFE). In some embodiments, thecontracting wire comprises a plurality of wires that are intertwined toform a rope structure.

Typically, structure 100 is shaped to provide at least one longitudinallumen for passage therethrough of ratchet body 202 and the contractingwire. In some embodiments, structure 100 is shaped to provide a firstlongitudinal lumen passage therethrough of the contracting wire and asecond longitudinal lumen for passage therethrough of ratchet body 202.

Fixed end 210 is fixed within a substantially tubular ratchet-couplinghousing 610, while dynamic end 220 slides through housing 610 along atrack 642 in the direction as indicated by the arrow. Ratchet body 202is shaped to define a plurality of first engaging structures, e.g.,first grooves 620, which are engageable by a tooth 612 of housing 610.As dynamic end 220 is slid away from fixed end 210 (i.e., in thedirection as indicated by the arrow), grooves 620 are engaged by asecond engaging structure, e.g., tooth 612, thereby allowing ratchetbody 202 to slide in only one direction, i.e., the direction in whichdynamic end 220 is first fed through housing 610 and as indicated by thearrow. As dynamic end 220 advances beyond fixed end 210, dynamic end 220slides alongside the portion of body 202 that is adjacent to fixed end210.

Each anchor mount 461 is shaped to provide at least one longitudinalanchor mount lumen having an axis that is parallel with the longitudinalaxis of the annuloplasty structure. The anchor mount lumen facilitatespassage therethrough of ratchet body 202 and the contracting wire. Insome embodiments, each anchor mount 461 is shaped to provide a firstlongitudinal lumen passage therethrough of the contracting wire and asecond longitudinal lumen for passage therethrough of ratchet body 202.

Each anchor mount 461 is shaped to provide an anchor channel for passagetherethrough of a helical anchor 740. As will be described hereinbelow,the channel is shaped to define a lumen having a channel axis that isdisposed at a non-zero angle, e.g., transverse, with respect to alongitudinal axis of the longitudinal lumen of the anchor mount throughwhich ratchet body 202 and the contracting wire pass. As such, inresponse to pulling of the contracting wire, the resultant sliding ofportions of the contracting wire and of ratchet body 202 through thelongitudinal lumen mount 461, does not interfere with the anchor channeland anchor 740 disposed therein. The angle of the anchor channel withrespect to the longitudinal lumen of anchor mount 461 facilitatescorkscrewing of the anchor into the annulus of the valve of the patientat an angle as defined by the intersecting axes of the anchor channeland the longitudinal lumen of mount 461, as described hereinbelow withreference to FIG. 8.

Typically, for embodiments in which annuloplasty structure 100 comprisesa plurality of anchor mounts 461, the respective angles defined by theintersecting axes of each anchor channel with the respective axis of thelongitudinal lumen of each mount 461 is identical for all mounts 461.Alternatively, a first portion of the plurality of anchor mounts 461 hasan angle that differs from the angle of a second portion of theplurality of anchor mounts. For example, a portion of anchor mounts 461designated to be anchored to the anterior portion of the annulus has anangle that is different from a portion of anchor mounts 461 designatedto be anchored to the posterior portion of the annulus. Thus, theanchors may be anchored to different portions of the annulus atdifferent angles in response to a need therefor.

It is to be noted that although helical anchors 740 are used incombination with structure 100, any anchor described herein may be usedin combination with structure 100.

For embodiments in which structure 100 is implanted during an open-heartor minimally-invasive procedure, structure 100 is advanced toward thevalve in a closed configuration (e.g., substantially ring-shaped or“D”-shaped), as shown. It is to be noted that structure 100 may beadvanced toward the valve of the patient in a linear configurationduring an open-heart or minimally-invasive valve repair procedure. Insuch an embodiment, once structure 100 is properly positioned within theleft atrium of the heart, the contracting wire (not shown) is pulled andfirst and second ends 102 and 104 of annuloplasty structure 100 aredrawn toward each other such that structure 100 assumes its closedconfiguration.

For embodiments in which structure 100 is advanced during a percutaneousvalve repair procedure, structure 100 is manufactured having a first end102 that is typically coupled to, e.g., welded to, housing 610 and asecond end 104 that is not coupled to housing 610 during the advancing.Thus, structure 100, in such an embodiment, is advanced toward the leftatrium of the patient in a generally linear configuration thereof.

For embodiments in which structure 100 is advanced toward the valve in alinear configuration, second end 104 is coupled to an engaging structureconfigured to engage housing 610 as structure 100 is made to assume itsclosed configuration. In some embodiments, the engaging structurecoupled to second end 104 comprises a tube having a diameter that issmaller than an inner diameter of housing 610 and is configured to slidewithin housing 610 as structure 100 is drawn into its closedconfiguration.

Housing 610 comprises first and second coupling sites 650 and 660, forcoupling of first end 102 and second end 104 of structure 100,respectively, to housing 610.

It is to be noted that annuloplasty structure 100 may be usedindependently of ratchet mechanism 600. For example, annuloplastystructure 100 may comprise only the contracting wire passing through thelumen of structure 100. In such an embodiment, once annuloplastystructure 100 is deployed from its linear state, the respective ends ofthe contracting wire are: (1) pulled such that the annuloplastystructure assumes its closed configuration, and (2) locked together inorder to maintain the closed configuration.

As described herein, structure 100 typically comprises a braided mesh inembodiments in which sutures pass through structure 100 and facilitateanchoring or suturing of structure 100 to the annulus. For embodimentsin which annuloplasty structure 100 is positioned using an open-heartprocedure, the mesh facilitates suturing of structure 100 to the annulusof the patient. In such an embodiment, the physician passes the suturethrough the mesh at a first location thereof, through tissue of theannulus, and subsequently, through a second location of the mesh,thereby suturing structure 100 to the annulus. In some embodiments, thesuturing is performed following placement of the annuloplasty structurealong the annulus. In some embodiments, a plurality of sutures aresutured to the annulus of the patient and the annuloplasty structure isslid along the sutures and toward the annulus. In such an embodiment,respective ends of each of the plurality of sutures are threaded throughthe mesh prior to the sliding, and are knotted together and clippedfollowing the sliding. The knotting of the sutures maintains thepositioning of the annuloplasty structure along the annulus.

For some embodiments, the mesh facilitates anchoring of the annuloplastystructure to the annulus of the patient. In such an embodiment, thephysician passes the anchor through the mesh at a first location thereofand then through tissue of the annulus.

It is to be understood that the braided mesh may be used independentlyof or in combination with the compressible subunits and/or with theanchor mounts. For example, the mesh may surround at least compressiblesubunits 450 of structure 100. Alternatively, the braided mesh may beused independently of compressible subunits 450 and/or anchor mounts461. In such an embodiment, structure 100 may comprise only ratchetmechanism 600 and/or the contracting wire surrounded by a sheath ofbraided mesh.

Reference is now made to FIG. 2A, which is a schematic illustration of aflat-ribbon ratchet mechanism 200, in accordance with an embodiment ofthe present invention. Typically, ratchet mechanism 200 is used incombination with annuloplasty structure 100 as described hereinabovewith reference to FIG. 1, in accordance with an embodiment of thepresent invention. It is to be noted that ratchet mechanism 200 may beused in combination with any of the annuloplasty structures describedherein. Ratchet mechanism 200 comprises a ratchet body 202 defining aflat ribbon having a proximal fixed end 210 and a distal dynamic end220. Although FIG. 1 shows ratchet mechanism 600 disposed withinannuloplasty structure 100, it is to be noted that ratchet mechanism 200may be disposed within annuloplasty structure 100. Ratchet mechanism 200is disposed within the lumen of structure 100 such that fixed end 210 isdisposed within the lumen of structure 100 in the vicinity of first end102 thereof, and dynamic end 220 is disposed within the lumen ofstructure 100 in the vicinity of second end 104 thereof.

As described hereinabove, in some embodiments, structure 100 is advancedtoward the left atrium of the patient in a generally linearconfiguration. Although ratchet body 202 is shown in a linearconfiguration, it is to be noted that ratchet body 202 is later drawninto a closed configuration (e.g., substantially ring-shaped or“D”-shaped configuration) simultaneously with structure 100 assuming itsclosed configuration (e.g., substantially ring-shaped or “D”-shapedconfiguration). As the contracting wire is pulled and first and secondends 102 and 104 of annuloplasty structure 100 are drawn toward eachother such that structure 100 assumes its closed configuration, dynamicend 220 is advanced past fixed end 210 such that ratchet body 202assumes its closed configuration as well. As dynamic end 220 advancesbeyond fixed end 210, dynamic end 220 and the distal portion of body 202are slid alongside fixed end 210 and the proximal portion of body 202.Dynamic end 220 and fixed end 210 are able to meet each other due to thesliding of ratchet body 202 along a track within the a respective lumenof each anchor mount 461 of structure 100, as will be describedhereinbelow.

Ratchet body 202 is shaped to define a plurality, e.g., at least two asshown, of first engaging structures, e.g., first windows 204, in thevicinity of dynamic end 220 and a plurality of second windows 206 in thegeneral vicinity of the middle of ratchet body 202. It is to be notedthat the number of second windows 206 is shown by way of illustrationand not limitation. Fixed end 210 is shaped to define a second engagingstructure, e.g., a tooth 230, which projects angularly away from alongitudinal axis of ratchet body 202 and is configured to engage thefirst engaging structures, e.g., windows 204 and 206. Fixed end 210 isshaped to define a slit 240 surrounding tooth 230. As ratchet mechanism200 is initially drawn into its closed configuration, dynamic end 220slides alongside tooth 230 and slit 240 of fixed end 210.

Ratchet body 202 provides a portion 222 disposed between first windows204 and second windows 206. Typically, portion 222 provides a smoothsurface for unobstructed back and forth sliding of dynamic end 220 pastfixed end 210 and enables the physician to adjust the size/perimeter ofthe annuloplasty structure before it is positioned along the annulus.Additionally, portion 222 enables the physician to adjust thesize/perimeter of the ratchet mechanism 200 prior to being locked inplace in response to the engaging of second windows 206 by tooth 230.Typically, portion 222 has a distance Di3 that is between 30 mm and 70mm, e.g., 50 mm.

For embodiments in which ratchet mechanism 200 is disposed withinstructure 100, ratchet mechanism 200 is typically disposed alongside theportion of contracting wire 110 which is disposed within the lumen ofstructure 100. As structure 100 is pulled into its closed configurationin response to the pulling of contracting wire 110, dynamic end 220 ispulled toward fixed end 210. Dynamic end 220 is passively advancedalongside fixed end 210 due to the compression force applied bystructure 100 in response to the pulling of contracting wire 110. Thatis, dynamic end 220 is not pulled by contracting wire 110, rather it ispassively pushed in response to the pulling of wire 110. Additionally,wire 110 is aligned alongside an external surface of ratchet body 202and at an external perimeter thereof. In response to pulling ofcontracting wire 110, contracting wire 110 pushes against the externalsurface of ratchet body 202 and applies a compression force thereto.Responsively to the compression force of wire 110 on the externalsurface of ratchet body 202, ratchet body 202 passively compresses.Further additional pulling of wire 110 reduces the perimeter of ratchetmechanism 200, and thereby of structure 100.

In response to continued pulling of contracting wire 110, structure 100radially contracts and, in turn, applies an additional compression forceto ratchet mechanism 200. In response to the compression force to theratchet mechanism by structure 100, ratchet body 202 radially contractsas dynamic end 220 is passively slid further distally away from fixedend 210 thereby drawing second windows 206 closer toward tooth 230 offixed end 210. Dynamic end 220 is slid distally away from fixed end 210until tooth 230 engages a first window 208 of second windows 206. Tooth230 remains locked in position with respect to first window 208 until anadditional compression force is applied to ratchet body 202 in responseto additional pulling of contracting wire 110. This additional forceslides dynamic end 220 even further away from fixed end 210 until tooth230 engages a second window 209 of second windows 206. Tooth 230prevents ratchet body 202 from sliding in an opposite direction withrespect to the direction by which dynamic end 220 is fed beyond fixedend 210. Thus, second windows 206 maintain respective ratchetedperimeters of the now substantially ring-shaped or “D”-shaped ratchetbody 202, and thereby maintain respective ratcheted perimeters ofstructure 100.

Alternatively, for some embodiments, dynamic end 220 is shaped to defineone or more holes configured for looping of contracting wire 110therethrough. In such an embodiment, dynamic end 220 is pulled inresponse to tensile force applied to contracting wire 110 as it ispulled. Additional force applied to wire 110 pulls ratchet mechanism 200into a closed configuration, e.g., a substantially ring-shapedconfiguration.

For embodiments in which structure is advanced toward the left atrium inits closed configuration, prior to the advancing, the physician formsstructure 100 into a closed configuration by advancing dynamic end 220beyond fixed end 210 until first windows 204 are in alignment with tooth230 and ratchet body 202 locks in place. At this stage, structure 100defines a generally ring-shaped structure having a relatively largeperimeter. As described hereinabove, once positioned along the annulusof the patient, the physician pulls wire 110 and dynamic end 220 slidesand is pushed further away from fixed end 210 until second windows 206lock and maintain a reduced perimeter of ratchet body 202, and thereby,structure 100.

It is to be noted that the plurality of second windows 206 are providedsuch that ratchet body 202, and thereby structure 100, can lock in placeand maintain respective ratcheted perimeters thereof. Thus, the lengthof ratchet mechanism 200 in its linear configuration, the lockingmechanism of ratchet mechanism 200, and compressible subunits 450described hereinabove are provided so as to enable annuloplastystructure 100 to accommodate various sizes of dilated annuli of givenpatients. Additionally, ratchet mechanism 200 facilitates: (1)positioning and anchoring structure 100 along the dilated annulus whilebody 202 (and thereby structure 100) has a first perimeter thereof, (2)contracting the dilated annulus in response to the contracting of body202 (and thereby structure 100), and (3) maintaining the contractedstate of the annulus while body 202 (and thereby structure 100) has asecond perimeter thereof that is typically smaller than the firstperimeter.

It is to be further noted that ratchet mechanism 200 is described hereinas being used in combination with structure 100 by way of illustrationand not limitation. For example, ratchet mechanism 200 may be surroundedby a tubular sheath comprising a braided mesh, e.g., metal or fabricsuch as polyester. The braided mesh facilitates passage of sutures orlongitudinal guide members through the sheath in order to anchor orsuture the sheath to the annulus. In some embodiments, during expansionof the sheath, by pulling on opposite ends thereof, the braided mesh islongitudinally pulled such that the mesh decreases in diameter, i.e.,the transverse cross-sectional diameter that is perpendicular withrespect to the longitudinal axis of structure 100. During contraction ofthe sheath from its relaxed state, the mesh is compressed such that thediameter of the mesh closely resembles the diameter of the mesh in itsrelaxed state.

FIG. 2B shows ratchet mechanism 200 as described hereinabove withrespect to FIG. 2A, with the exception that fixed end 210 is shaped todefine a housing 250, in accordance with an embodiment of the presentinvention. Typically, housing 250 of fixed end 210 is shaped to definetooth 230 and slit 240 and is configured to receive dynamic end 220 in amanner as described hereinabove with respect to FIG. 2A. Typically,housing 250 is configured to provide stability to mechanism 200 duringthe aligning of windows 204 and 206 with tooth 230 of fixed end 210.

During the initial contraction of structure 100, dynamic end 220 is fedinto housing 250. As described hereinabove, ratchet body 202 assumes aclosed configuration as dynamic end 220 is initially locked in placewhen tooth 230 of housing 250 engages first windows 204. A compressionforce is further applied to ratchet body 202 (e.g., a radial force or atensile force applied in response to pulling the contracting wire, asdescribed hereinabove) which further advances dynamic end 220 away fromhousing 250.

FIG. 3 shows a system 300 comprising ratchet body 202 passing through afirst one of anchor mounts 461 of annuloplasty structure 100, inaccordance with an embodiment of the present invention. Anchor mount 461comprises a lateral-aperture anchor mount 341 which comprises asubstantially hollow, tubular element 463 configured for passagetherethrough of ratchet body 202 and contracting wire 110. The anchormount shown is configured to fix in place fixed end 210 of ratchet body202. It is to be noted that anchor mount 341 may fix in place any of theratchet bodies described herein. Additionally, anchor mount 341 isshaped to define an aperture 340 configured for passage therethrough ofan anchor, as will be described hereinbelow. In some embodiment, atubular channel (configuration shown hereinbelow with reference to FIG.4) for passage of an anchor is coupled to, e.g., welded to, mount 341along portions of mount 341 which define aperture 340. As shown,aperture 340 is provided at a location along mount 461 such that passageof a tissue anchor therethrough (e.g., directly or indirectly through achannel coupled to portions of mount 341 defining aperture 340), doesnot interfere with contracting wire 110 and/or ratchet body 202 disposedwithin the annuloplasty structure.

It is to be noted that only one anchor mount 341 is shown for clarity ofillustration. For example, ratchet mechanism 200 may be coupled to aplurality of anchor mounts 341 which are disposed at various sites withrespect to ratchet body 202. It is to be further noted that a respectivecompressible subunit 450 may be coupled to either end of anchor mount341. As shown, anchor mount 461 is shaped to define a first couplingsite 302 and a second coupling site 304. For embodiments in whichratchet mechanism 200 is used in combination with compressible subunits450, as described hereinabove with reference to FIG. 1, a respectivecompressible subunit 450 is coupled to coupling sites 302 and 304.

Reference is now made to FIG. 4, which is a schematic illustration ofsystem 300 comprising a tissue anchor 360 coupled to anchor mount 341,in accordance with an embodiment of the present invention. Anchor mount341 fixes in place fixed end 210 of ratchet body 202 as describedherein. Ratchet body 202 of FIG. 3 is shown in an open, linearconfiguration thereof, i.e., dynamic end 220 is not aligned alongsidefixed end 210. An anchor 360 is shown coupled to mount 461. In someembodiments, a tube-channel 1200 (as described in more detailhereinbelow with reference to FIG. 11) is coupled to mount 461 portionsof mount 341 defining aperture 340. In some embodiments, channel 1200 iswelded to mount 461 during the manufacturing of mount 341.

In some embodiments, tube-channel 1200 is not welded to mount 341 butrather is advanced toward mount 341 together with, e.g., surrounding,anchor 360. In such an embodiment, channel 1200 is free to rotate withrespect to aperture 340 along the longitudinal axis of mount 341.

As shown, anchor 360 is shaped to define a helix having a pointed distalend 370 which punctures through tissue of the annulus of the heart. Itis to be noted that a helical anchor is shown by way of illustration andnot limitation, and that any suitable anchor may be used to anchor theannuloplasty structure to the annulus. For embodiments in which ahelical anchor is used, tube-channel 1200 may comprise a bar, asdescribed in U.S. Provisional Patent Application 61/001,013, PCT PatentApplication PCT/IL07/001503, which published as WO 08/068756, and U.S.patent application Ser. No. 11/950,930 to Gross et al., entitled,“Segmented ring placement” which published as US 2008/0262609 and whichissued as U.S. Pat. No. 8,926,695. This bar is configured to restrictcontinued corkscrewing of helical anchor 360 into the tissue of theannulus beyond a predetermined distance, e.g., between 3 mm and 10 mm.Additionally, the bar functions as a nut providing a thread for thehelical anchor to be advanced distally and corkscrewed around the barand into the tissue of the annulus.

As shown, helical anchor 360 is coupled at a proximal end thereof (i.e.,the portion of anchor 360 that is not configured to be advanced into theannulus tissue) to a head portion 380. Typically, a distal end of headportion 380 has a diameter that is larger than a diameter oftube-channel 1200. Once anchor 360 is advanced distally throughtube-channel 1200, the distal portion of head portion 380 abuts aproximal portion of tube-channel 1200 and prevents continued distalmotion of anchor 360. Even when head portion 380 abuts tube-channel1200, anchor 360 is allowed to continue rotational motion. Thiscontinued rotational motion draws tissue of the annulus toward theannuloplasty structure. In the event that a gap between the annulustissue and the annuloplasty structure is created during the initialanchoring of the structure to the annulus of the valve, the continuedrotation of anchor 360 minimizes and substantially eliminates the gap.As shown, head portion 380 is shaped to define one or more, e.g., two asshown, engaging elements, e.g., holes, 390. In some embodiments,engaging elements 390 are configured for coupling and/or passagetherethrough of an actuation means by way of illustration and notlimitation, and the anchoring means is configured to corkscrew theanchor into the tissue of the annulus.

It is to be noted that engaging elements 390 are shown as being circularby way of illustration and not limitation, and that elements 390 may beshaped to define any suitable shape, e.g., rectangles, ovals, etc.

Typically, head portion 380 prevents continued distal motion of anchor360 into the annulus with respect to the distal surface of the anchormount, i.e., the portion of the mount designated to align with andcontact the annulus. For embodiments in which tube-channel 1200 isadvanced together with anchor 360, the tube-channel 1200 rotates withinaperture 340 along the longitudinal axis of mount 461 together with therotating of anchor 360.

Reference is now made to FIGS. 5A-C, which are schematic illustrationsof system 300 as described hereinabove with reference to FIG. 4, withthe exception that anchor mount 461 comprises a transverse-lumen anchormount 342 comprising a tubular element 465 shaped to define an anchorlumen 501 having an longitudinal axis 502 thereof, in accordance with anembodiment of the present invention. Tubular element 465 fixes in placefixed end 210 of ratchet body 202 as described hereinabove withreference to FIG. 2A. Typically, anchor mount 461 provides at least onelongitudinal anchor mount lumen having an axis that is parallel with thelongitudinal axis of the annuloplasty structure. Anchor mount lumenfacilitates passage therethrough of ratchet mechanism 200 andcontracting wire 110. Longitudinal axis 502 of anchor lumen 501 is at anon-zero angle, e.g., transverse, with respect to the longitudinal axisof the anchor mount lumen of anchor mount 461. Transverse lumen 501 isshaped to facilitate passage therethrough of tube-channel 1200, asdescribed hereinabove with reference to FIG. 4. As shown, transverselumen 501 does not interfere with ratchet body 202 and contracting wire110.

Reference is now made to FIGS. 5A-B. Anchor mount 461 is coupled ateither end thereof to a respective stabilizing structure 310. Typically,since anchor mount 461 comprises hollow tubular element 465, anchormount 461 has a tendency to pivot laterally with respect to ratchet body202. Stabilizing structure 310 is shaped to define mounts 312 which areconfigured to surround and lock in place a portion of anchor mount 461and to prevent swiveling thereof. Ratchet body 202 passes throughaperture 330 of stabilizing structure 310 and through the longitudinalanchor mount lumen. Passing of ratchet body 202 through structure 310and then through mount 461 locks in place stabilizing structure 310which, in turn, locks in place anchor mount 461 and prevents it frompivoting laterally. Additionally, aperture 330 of stabilizing structure310 provides a suitable track for advancement of ratchet body 202 alonga defined path. For example, this track enables the proper positioningof dynamic end 220 with respect to fixed end 210.

Typically, aperture 330 has a major axis 331 and has a longitudinal axis332 that is transverse with respect to major axis 331. Major axis 331 ofaperture 330 is typically disposed at a non-zero angle with respect toaxis 502 of anchor lumen 501. A portion of ratchet body 202 passesthrough aperture 330 along longitudinal axis 332 thereof. Typically,ratchet body 202 passes through aperture 330 of a first stabilizingstructure 310, through the lumen of anchor mount 461, and subsequentlythrough aperture 330 of a second stabilizing structure 310. Prior to thecoupling of mount 461 to a pair of structures 310, mount 461, andthereby lumen 501, is allowed to pivot laterally. Following the couplingof structures 310 to mount 461, structures 310 restrict the lateralpivoting of mount 461.

During the manufacture of structure 310, aperture 330 is created suchthat major axis 331 is disposed at a desired angle with respect to axis502 of anchor lumen 501 when coupled to mount 461. A portion of ratchetbody 202 is then passed through mount 461 and subsequently throughaperture 330, thereby fixing the angle of the major axis of aperture 330with respect to axis 502 of anchor lumen 501. Typically, (a)longitudinal axis 332 of aperture 330 is substantially parallel withrespect to a plane of the annulus and parallel with the longitudinalaxis of the annuloplasty structure, and (b) axis 502 of anchor lumen 501is at a non-zero angle with respect to major axis 331 of the aperture330. Thus, the angle of anchor lumen 501 with respect to longitudinalaxis 332 facilitates corkscrewing of the tissue anchor into the annulusat an angle as defined by the intersecting axes 502 of lumen 501 andmajor axis 331 of aperture 330 (shown in FIG. 5C).

For embodiments in which system 300 comprises a plurality of anchormounts 461, the respective pairs of structures 310 coupled on either endof each mount 461 may be manufactured differently. For example, (1) afirst pair of structures 310 may be shaped to define apertures 330having a major axis at a first desired angle with respect to axis 502 ofanchor lumen 501 of a first anchor mount 461, and (2) a second pair ofstructures 310 may be shaped to define apertures 330 having a major axisat a second desired angle with respect to the longitudinal axis ofanchor lumen 501 of a second anchor mount 461. Thus, the respectiveanchors configured to be passed through each of the first and secondanchor mounts are anchored to the tissue at the desired first and secondangles, respectively. In some embodiments, the anchors which passthrough the anchor mounts positioned along the annulus in alignment withthe base of the posterolateral leaflet may be anchored at an angle thatis different from an angle at which the anchors which pass through theanchor mounts positioned along the annulus in alignment with the base ofthe anteromedial leaflet are anchored.

FIG. 5C shows a perspective view of system 300 from an opposite viewthan that shown in FIG. 5A. Ratchet body 202 passes unobstructedalongside anchor lumen 501 of anchor mount 461. As describedhereinabove, anchor mount 461 may also function as a housing for fixedend 210 of ratchet body 202. Anchor mount 461 is shaped to define a slit520 which engages and fixes in place a portion 212 of fixed end 210.Typically, portion 212 projects away perpendicularly from a longitudinalaxis of ratchet body 202.

Reference is now made to FIGS. 3 and 5B-C. Anchor mount 461 is flankedby stabilizing structures 310. FIG. 5B shows a stabilizing unit 500having a stabilizing structure 310 is shaped to define: (1) a hole 320configured for passage therethrough of contracting wire 110, and (2) alongitudinal aperture 330 configured for passage therethrough of ratchetbody 202, in accordance with an embodiment of the present invention.Typically, aperture 330 has a width L7 of between 0.3 mm and 0.8 mm.Such a width facilitates passage therethrough of at least a portion ofratchet body 202. For embodiments in which a first portion of body 202is slid alongside a second portion of body 202 (e.g., dynamic end 220slides alongside fixed end 210), width L7 accommodates for the widths ofboth the first and second portions of ratchet body 202 and facilitatespassage therethrough of both portions.

FIG. 3 shows ratchet body 202 in a closed configuration thereof. It isto be noted that ratchet body 202 assumes a substantially circularconfiguration thereof and that only a portion of ratchet body 202 isshown. Typically, dynamic end 220 is passively fed through aperture 330alongside fixed end 210. As such, a portion of body 202 distal to fixedend 210 aligns alongside a portion proximal to dynamic end 220, as shownin FIG. 3. Thus, width L7 of aperture 330 accommodates for the widthsof: (1) the portion of body 202 distal to fixed end 210, and (2) theportion of body 202 proximal to dynamic end 220.

Reference is now made to FIGS. 6A-B which are schematic illustrations ofa ratchet mechanism 600, in accordance with an embodiment of the presentinvention. Ratchet body 202 is shaped to define dynamic distal end 220and fixed proximal end 210. As shown, ratchet body 202 is shaped todefine a plurality of first engaging structures, e.g., grooves 622,configured to be engaged by a second engaging structure, a tooth 612, atfixed end 210. Fixed end 210 is coupled to a substantially tubularratchet-coupling housing 610 which is shaped to define a first couplingsite 650 and a second coupling site 660. For embodiments in whichratchet mechanism 600 is used in combination with compressible subunits450 as described hereinabove with reference to FIG. 1, a respectivecompressible subunit 450 is coupled to coupling sites 650 and 660.

As described hereinabove with reference to FIG. 1, ratchet mechanism 600is disposed within the lumen of structure 100 such that fixed end 210 isdisposed within the lumen of structure 100 in the vicinity of first end102 thereof and dynamic end 220 is disposed within the lumen ofstructure 100 in the vicinity of second end 104 thereof. Althoughratchet body 202 is shown in a linear configuration, it is to be notedthat ratchet body 202 is drawn into its closed configurationsimultaneously with structure 100 assuming its closed configuration. Ascontracting wire 110 is pulled and first and second ends 102 and 104 ofannuloplasty structure 100 are drawn toward each other such thatstructure 100 assumes its closed configuration, dynamic end 220 is fedinto housing 610 and is advanced past fixed end 210 such that ratchetbody 202 assumes its closed configuration as well. As dynamic end 220advances beyond fixed end 210, dynamic end 220 and the portion of body202 that is proximal to end 220 are slid alongside fixed end 210 and theportion of body 202 that is distal to fixed end 210. As shown, housing610 is coupled to an insert 640 that is shaped to define a longitudinaltrack 642. As dynamic end 220 is fed into housing 610 of fixed end 210,dynamic end slides along track 642. Thus, dynamic end 220 and fixed end210 are able to meet each other due to the sliding dynamic end 220 alongtrack 642 within the lumen housing 610.

Ratchet body 202 is shaped to define a plurality, e.g., at least two asshown, of first grooves 620 in the vicinity of dynamic end 220 and aplurality of second grooves 630 in the general vicinity of the middle ofratchet body 202. It is to be noted that the respective numbers of firstgrooves 620 and second grooves 630 are shown by way of illustration andnot limitation. As ratchet mechanism 600 is initially drawn into itsclosed configuration, dynamic end 220 slides alongside track 642 andtooth 612 engages respective grooves 622 of ratchet body 202.

Ratchet body 202 provides a portion 222 disposed between first grooves620 and second grooves 630. Typically, portion 222 provides a smoothsurface for unobstructed back and forth sliding through fixed end 210and enables the physician to adjust the size/perimeter of theannuloplasty structure before it is positioned along the annulus.Additionally, portion 222 enables the physician to adjust thesize/perimeter of ratchet mechanism 600 prior to the locking of secondgrooves 630 by tooth 612. Typically, portion 222 has a distance that isbetween 30 mm and 70 mm, e.g., 50 mm.

It is to be noted that ratchet mechanism 600 may be anchored to theannulus independently of annuloplasty structure 100 describedhereinabove with reference to FIG. 1 and with reference to ratchetmechanism 200 described hereinabove with reference to FIGS. 2A-B.Alternatively, for embodiments in which ratchet mechanism 600 isdisposed within structure 100, ratchet mechanism 600 is typicallydisposed alongside the portion of contracting wire 110 which is disposedwithin the lumen of structure 100. As structure 100 is pulled into itsclosed configuration in response to the pulling of contracting wire 110,dynamic end 220 is pulled toward fixed end 210. Dynamic end 220 ispassively advanced within housing 610, typically alongside fixed end210, due to the compression force applied by structure 100 in responseto the pulling of contracting wire 110.

In response to continued pulling of contracting wire 110, structure 100radially contracts and, in turn, applies an additional compression forceto ratchet mechanism 600. As described hereinabove, in response to thecompression force, ratchet body 202 radially contracts as dynamic end220 is passively slid further distally away from fixed end 210 therebydrawing second grooves 630 closer toward tooth 612 of housing 610.Dynamic end 220 is slid distally away from fixed end 210 until tooth 612engages a first groove 624 of second grooves 630. Tooth 612 remainslocked in position with respect to first groove 624 until an additionalcompression force of structure 100 is applied to ratchet body 202 (i.e.,in response to the pulling of contracting wire 110). This additionalforce slides dynamic end 220 even further away from fixed end 210 untiltooth 612 engages a second groove 626 of second grooves 630. Tooth 612prevents body 202 of mechanism 600 from sliding in an opposite directionwith respect to the direction by which dynamic end 220 is fed beyondfixed end 210. Thus, second grooves 630 maintain respective ratchetedperimeters of the now closed ratchet body 202, and thereby maintainrespective ratcheted perimeters of structure 100.

For embodiments in which structure is advanced toward the left atrium inits closed configuration (e.g., during an open-heart procedure or duringa minimally-invasive procedure), dynamic end 220 is advanced past fixedend 210 until first grooves 620 are in alignment with tooth 612 andratchet body 202 is locked in an expanded configuration thereof and hasa relatively large perimeter. As described hereinabove, once positionedalong the annulus of the patient, the dynamic end 220 is pushed furtherdistally away (i.e., in the direction as indicated by the arrow in FIG.6B) from fixed end 210 until locking grooves 630 lock and fix aperimeter of body 202, and thereby, fix a perimeter of structure 100.

It is to be noted that the plurality of second grooves 630 is providedsuch that ratchet body 202, and thereby structure 100, can lock in placeand maintain respective ratcheted perimeters thereof. Thus, the lengthof ratchet mechanism 600 in its linear configuration, the lockingmechanism of ratchet mechanism 600, and compressible subunits 450described hereinabove are provided so as to enable annuloplastystructure 100 to accommodate various sizes of dilated annuli of givenpatients. Additionally, ratchet mechanism 600 facilitates: (1)positioning and anchoring structure 100 along the dilated annulus whilebody 202 (and thereby structure 100) has a first perimeter thereof, (2)contracting the dilated annulus in response to the contracting of body202 (and thereby structure 100), and (3) maintaining the contractedstate of the annulus while body 202 (and thereby structure 100) has asecond perimeter thereof that is typically smaller than the firstperimeter.

It is to be further noted that ratchet mechanism 600 is described asbeing used in combination with structure 100 by way of illustration andnot limitation. For example, ratchet mechanism 600 may be surrounded bya tubular sheath comprising a braided mesh, e.g., metal or fabric suchas polyester.

FIG. 6B shows dynamic end 220 having already passed through housing 610of fixed end 210. As such, ratchet body 202 assumes a closedconfiguration (partially shown for clarity of illustration). As shown,dynamic end 220 is shaped to define one or more holes 613 configured forlooping of the contracting wire therethrough. In such an embodiment,dynamic end 220 is pushed in response to tensile force applied to thecontracting wire as it is pulled. As described hereinabove, additionalforce applied to the contracting wire pushes ratchet mechanism 200 intoa closed configuration, e.g., a substantially ring-shaped configuration.Further additional pulling of the contracting wire reduces the perimeterof ratchet mechanism 600, and thereby of the annuloplasty structure.

FIG. 7 shows ratchet mechanism 600 as described hereinabove withreference to FIGS. 6A-B, with the exception that housing 610 provides atooth 712 is shaped to define a window 714, in accordance with anembodiment of the present invention. Tooth 712 is coupled to housing 610along a junction and bends along the junction. As tooth 712 engagesgroove 620 of ratchet body 202, window 714 surrounds a portion 772 of anupper surface 770 of ratchet body 202 which defines groove 620. Window714 thus enables tooth 712 to advance distally and bend as far aspossible within groove 620 without being obstructed by portion 772 ofupper surface 770 which defines groove 620. Tooth 712 engages groove 620and locks ratchet body 202 in place until an additional inward, radialpushing force is applied thereto, e.g., typically, in response to thepulling of contracting wire 110 described herein. In response to theadditional inward, radial force applied to ratchet body 202, (a) dynamicend 220 is slid further away from housing 610 in the same direction inwhich dynamic end 220 was initially fed into housing 610 (i.e., thedirection as indicated by the arrow), and (b) tooth 712 slides alongupper surface 770 of ratchet body 202 until tooth 712 engages anothergroove 620 of ratchet body 202.

Dynamic end 220 is shaped to define one or more holes 613 configured forlooping of the contracting wire therethrough. In such an embodiment,dynamic end 220 is pulled in response to tensile force applied to thecontracting wire as it is pulled. Additional force applied to thecontracting wire pulls ratchet mechanism 600 into the closedconfiguration. Further additional pulling of the contracting wirereduces the perimeter of ratchet mechanism 600, and thereby of theannuloplasty structure.

It is to be noted that ratchet body 202 may be pulled by contractingwire 110 in some embodiments. Ratchet body 202 is typically pushed inresponse to the radial, compressing force applied to body 202 by theannuloplasty structure in response to the pulling of contracting wire110.

Reference is now made to FIGS. 6A-B and 7. Fixed end 210 of ratchet body202 is shaped to define a protrusion 722 (not shown in FIGS. 6A-B).Housing 610 is shaped to define a slit (not shown for clarity ofillustration) for passage therethrough of protrusion 722 in order to fixfixed end 210 in place with respect to housing 610.

FIG. 8 shows an anchor mount system 900 comprising an anchor mount 461comprising a double-lumen anchor mount 343 that is shaped to define achannel 460 and a lumen 920, or channel, in accordance with anembodiment of the present invention. Anchor mount 461 is shaped todefine a lateral wall 467 having a first portion 464 and a secondportion 466 generally at opposite sites of mount 461 when viewed incross-section (e.g., at 12 o'clock and 6 o'clock). Typically, firstportion 464 is shaped to define an opening thereof, and second portion466 is shaped to define an opening thereof. Channel 460 extends from theopening of first portion 464, through the anchor mount, to the openingin second portion 466. As described hereinabove with reference to FIG.1, anchor mount 461 is configured for facilitating passage therethroughany anchor described herein in order to facilitate anchoring of anannuloplasty structure (e.g., any annuloplasty structure comprisingmount system 900) to the annulus of the patient. Channel 460 has adiameter between about 0.8 mm and 2.5 mm, e.g., 1.8 mm, that is sized tofacilitate passage therethrough of any one of the anchors, anchoringstructures, or anchoring systems described herein. Typically, theanchors described herein are configured for passage through channel 460have a diameter of between about 0.5 mm and 2.4 mm, e.g., 1.6 mm.

First portion 464 of lateral wall 467 of mount 461 is shaped to define atapered opening 950 above channel 460. Opening 950 has a diameter thatis typically larger than a diameter D2 of channel 460. Typically, duringthe anchoring of the annuloplasty structure to the annulus, an anchor iscoupled to an advancement structure, e.g., a tube or a rod, at a distalend thereof and is advanced via the advancement structure toward channel460. In some embodiments, a portion of the distal end of the advancementstructure has a diameter that is slightly larger than the proximal endof channel 460, i.e., opening 950 of anchor mount 461. Thus, theadvancement of the advancement structure is restricted from passagethrough channel 460 beyond the portion of the distal end of the tubethat has a diameter larger than the diameter of channel 460. Thisrestriction helps ensure that the anchor is not advanced too deeplywithin tissue of the annulus.

In some embodiments, a proximal portion (e.g., the portion of the anchorthat is coupled to the distal end of the advancement structure) of theanchor is configured to expand. In such an embodiment, the proximalportion of the anchor is compressed within an overtube during theadvancement of the anchor toward the annulus of the valve. Once theanchor is positioned properly within channel 460 and is initiallyanchored to the annulus of the valve, the overtube is slid proximallyfrom the proximal end of the anchor and the proximal portion is allowedto expand. In such an embodiment, the expanded portion of the anchor hasa diameter that is (a) larger than diameter D2 of channel 460 and (b)smaller than the diameter at the distal end of opening 950. Thus, theexpanded, proximal portion of the anchor rests within the proximal endof opening 950 and functions as a cap which restricts further distaladvancement of the anchor into the tissue of the annulus.

Anchor mount 461 is shaped to provide an anchor mount and ratchet bodylumen 920 for passage of ratchet body 202 of any of the ratchetmechanisms described herein. Ratchet body lumen 920 has (a) alongitudinal axis 942 that is substantially parallel with respect to theplane of the annulus and parallel with the longitudinal axis of theannuloplasty structure, and (b) an axis 940 that is typically at anon-zero angle, e.g., transverse, with respect to longitudinal axis 942.Channel 460 has a first axis 930 is typically at a non-zero angle, e.g.,transverse, with respect to longitudinal axis 942. Typically, lumen 920is disposed with respect to channel 460 such that axis 940 of lumen 920is disposed at an angle theta, with respect to axis 930 of channel 460.Typically, the anchor is anchored at angle theta with respect to axes940 and 920 and the plane of the annulus of the valve. It is to be notedangle theta may range between 10 degrees and 70 degrees, typically 30degrees.

Typically, for embodiments in which the annuloplasty structure comprisesa plurality of anchor mount systems 900, angle theta is identical forall mounts 461. Alternatively, a first portion of the plurality ofanchor mount systems 900 has an angle theta that differs from the angletheta of a second portion of the plurality of anchor mount systems 900.For example, a portion of anchor mount systems 900 designated to beanchored to the anterior portion of the annulus has an angle theta thatis different from a portion of anchor mount systems 900 designated to beanchored to the posterior portion of the annulus. Thus, the anchors maybe anchored to different portions of the annulus at different angles inresponse to a need therefor.

In some embodiments, the contracting wire described herein passesthrough lumen 920 alongside ratchet body 202. In some embodiments, mount461 of system 900 is shaped to provide an additional distinct lumenconfigured for passage therethrough of the contracting wire(configuration not shown).

Anchor mount 461 comprises first and second coupling sites 960 and 970configured for coupling, e.g., wrapping therearound or welding,respective ends of one or more compressible subunits 450 as describedhereinabove.

FIG. 9 shows an anchor mount system 1000 comprising an anchor mount 461having a curved lateral surface 1100 that is coupled to an anchorchannel 350 for passage of an anchor therethrough, in accordance with anembodiment of the present invention. Anchor mount 461 is configured foruse in combination with any of the annuloplasty structures describedherein. Mount 461 and is shaped to define a first lumen 1010 configuredfor passage therethrough of the contracting wire and a second lumen 1020for passage therethrough of the ratchet body of any one of the ratchetmechanisms described herein. Lumens 1010 and 1020 facilitateunobstructed passage of the contracting wire and the ratchet body,respectively, with respect to the passage of an anchor through channel350.

As described hereinabove with respect to FIG. 8, lumen 1020 has a firstaxis 1022 and channel 350 has a second axis 1030 which is disposed at anangle theta (e.g., between 10 degrees and 70 degrees, typically 30degrees) with respect to first axis 1022. As such, the anchor passedthrough channel 350 is anchored to the annulus at angle theta withrespect to the ratchet body disposed within lumen 1020.

Anchor mount 461 comprises first and second coupling sites 1110 and 1112configured for coupling, e.g., wrapping therearound or welding,respective ends of one or more compressible subunits 450 as describedhereinabove.

FIG. 10 shows an anchor mount system 1111 comprising an anchor mount 461comprising lateral-aperture anchor mount 341 which is shaped to definean aperture 340 configured for passage therethrough of an anchor, asdescribed hereinabove with reference to FIG. 3, in accordance with anembodiment of the present invention. In some embodiments, the anchor isslid through aperture 340 and rests against portions 1142 of mount 461which define aperture 340. Typically, portions 1142 provide horizontalsurfaces 1140 which function as shelves impeding continued distal motionof an anchor configured to be advanced through aperture 340. In someembodiment, a channel for passage of the anchor is welded to mount 461along portions 1142 of mount 461. In some embodiments, the channel isadvanced toward mount 461 together with the anchor. In such anembodiment, the channel is free to rotate with respect to aperture 340along the longitudinal axis of mount 461.

Anchor mount 461 comprises a substantially tubular element 463 whichdefines a longitudinal anchor mount lumen. Aperture 340 is created at alocation of mount 461 such that passage of an anchor via aperture 340,directly or indirectly, does not interfere with the contracting wireand/or ratchet body disposed within the longitudinal lumen of mount 461.

Reference is now made to FIGS. 5C and 10. Anchor mount 461 alsofunctions as a housing for fixed end 210 of ratchet body 202. Anchormount 461 is shaped to define slit 520 which engages and locks portion212 of fixed end 210.

Anchor mount 461 comprises first and second coupling sites 112 and 114configured for coupling, e.g., wrapping therearound or welding,respective ends of one or more compressible subunits 450.

Reference is now made to FIG. 11, which is a schematic illustration ananchor tube-channel 1200 configured to be used in combination with anyone of anchor mounts 461 described herein, in accordance with anembodiment of the present invention. In some embodiments, anchor channel1200 is configured to be advanced through lumen 501 of anchor mount 461shown in FIGS. 5A and 5C. In some embodiments, channel 1200 is welded toanchor mount 461, shown in FIGS. 3, 4, and 10, via aperture 340. In someembodiments, during the manufacture of mount 461, channel 1200 is weldedvia surface 1100 to anchor mount 461, shown in FIG. 9, in place ofchannel 350.

Channel 1200 has (a) a proximal end 1250 which provides a passageway forpassage of an anchor through a channel 1210 of channel 1200, and (b) adistal end 1260 which typically rests against the annulus of the valvewhen the annuloplasty structure is positioned along the annulus.Proximal end 1250 of channel 1200 is shaped to define an external ring1220 having a diameter larger than the diameter of proximal end 1250 ofchannel 1200. For embodiments in which channel 1200 is configured to beadvanced distally through lumen 501 of anchor mount 461 shown in FIGS.5A and 5C, ring 1220 functions to impede continued distal motion ofchannel 1200 beyond a predetermined depth, as limited by ring 1220abutting a proximal opening of channel 1200 of anchor mount 461. In suchan embodiment, channel 1200 is free to rotate with respect to aperture340 along the longitudinal axis of mount 461.

Channel 1200 is shaped to define one or more (e.g., two, as shown)lateral slits 1230 and 1240. In some embodiments, a longitudinal bar(not shown) is configured to be welded between slits 1230 and 1240.Slits 1230 and 1240 enable the bar to be welded to channel 1200 in anygiven configuration, e.g., substantially perpendicularly to ordiagonally with respect to slits 1230 and 1240, and at any angle withrespect to slits 1230 and 1240. For embodiments in which the bar iswelded diagonally with respect to slits 1230 and 1240, a first end ofthe bar may be coupled to a portion of channel 1200 defining proximalend 1231 of slit 1230 while a second end of the bar is coupled to aportion of channel 1200 defining distal end 1242 of slit 1240, by way ofillustration and not limitation. For example, in some embodiments, thefirst end of the bar may be coupled to proximal end 1231 of slit 1230while the second end of the bar is coupled to a portion defining slit1240 that is between proximal end 1241 and distal end 1242 thereof. Forembodiments in which the bar is welded substantially perpendicularlywith respect to slits 1230 and 1240, the first and second ends of thebar may be coupled to: (1) proximal end 1231 of slit 1230 and proximalend 1241 of slit 1240, respectively, (2) distal end 1232 of slit 1230and distal end 1242 of slit 1240, respectively, or (3) parallel portionsof slits 1230 and 1240 that are between the respective distal andproximal ends of slits 1230 and 1240.

Typically, the bar provides a reference force to help corkscrew theanchor into tissue of the annulus during the initial corkscrewingthereof. Even when the bar restricts further distal motion of the anchorbeyond a predetermined distance (e.g., a predetermined distance fromthat lateral surface of mount 461 which rests against tissue of theannulus), the anchor is allowed to resume rotational motion togetherwith rotational motion of channel 1200 for embodiments in which channel1200 is not welded to anchor mount 461. In the event that a gap iscreated between the annulus tissue and the annuloplasty structure duringthe initial anchoring of the structure to the annulus of the valve, thiscontinued rotational motion draws tissue of the annulus toward theannuloplasty structure. Such proximal drawing of the tissue therebyminimizes and substantially eliminates the gap. Techniques for use witha helical anchor and the bar as described herein may be used incombination with techniques described in U.S. Provisional Application61/001,013 to Gross et al., entitled, “Segmented ring placement,” filedOct. 29, 2007, which is incorporated herein by reference.

FIG. 12 is a schematic illustration of an anchoring structure 1800comprising a tapered, conical helical element 1802 comprising aplurality of coils 1810, in accordance with an embodiment of the presentinvention. Typically, the plurality of coils 1810 comprises a pointeddistal end 1820 which punctures tissue of the annulus and allows forcoils 1810 to be corkscrewed distally into the tissue of the annulus. Aproximal surface of element 1802 is coupled to a head portion 1830comprising raised surfaces 1832 having a defined conformation. In someembodiments, head portion 1830 functions to prevent distal screwing ofstructure 1800 into the annulus of the patient beyond a predetermineddepth as defined by the combined length of head portion 1830 and coils1810. Although structure 1800 is not able to be advanced furtherdistally, continued rotation of structure 1800 draws tissue proximallywith respect to the annuloplasty structure, thereby substantiallyminimizing or eliminating a gap that may be created between theannuloplasty structure and the tissue of the annulus.

Typically, an anchor advancement structure, e.g., a tube or a rod, (notshown) is coupled at a distal end thereof to structure 1800 via raisedsurfaces 1832. In such an embodiment, the distal end of the advancementdevice is shaped to define recessed portions which are similar in shapeto the define conformation of raised surfaces 1832. The advancementdevice is coupled to structure 1800 when the recessed portions of thedevice accommodate the conformation of raised surfaces 1832 bysurrounding and locking in place surfaces 1832 with respect to therecessed portions of the advancement device. The advancement device islocked together with structure 1800 when a rotational force is appliedto the advancement force in a rotational direction as indicated by thearrow. Once the advancement device facilitates the anchoring ofstructure 1800 to the annulus of the patient, a rotational force isapplied to the anchor advancement structure in a direction opposite tothe direction indicated by the arrow which detaches the advancementdevice from structure 1800 by sliding the recessed portions of theadvancement device away from raised surfaces 1832.

For embodiments in which structure 1800 is used to percutaneously anchoran annuloplasty structure to the annulus, the anchor advancementstructure comprises an advancement structure, e.g., a tube or a rod,which is typically coupled to head portion 1830 prior to beingtranscatheterally advanced toward the annuloplasty structure. Forembodiments in which anchor structure 1800 is used to anchor theannuloplasty structure to the annulus during an open-heart procedure, anexternal anchoring device (e.g., an advancement tube, an advancementrod, or a screw-driving system) is used in order to facilitate anchoringof structure 1800 to the annulus.

In either embodiment, once the anchor advancement structure advances theanchor toward the annuloplasty structure, the anchor advancementstructure is rotated in order to facilitate corkscrewing of anchoringstructure 1800 into the annulus of the patient. For embodiments in whichthe compressible subunits of the annuloplasty structure comprise abraided mesh, as described hereinabove, structure 1800 may be advancedthrough the mesh and anchor the annuloplasty structure to the annulusvia the mesh. For embodiments in which the compressible subunits of theannuloplasty structure comprise a coiled structure, coils 1810 ofstructure 1800 are coiled around a portion of coils of the coiledcompressible subunits of the annuloplasty structure and subsequentlythrough the tissue of the annulus of the patient. During the coiling ofcoils 1810 of structure 1800 around the portion of coils of the coiledcompressible subunits of the annuloplasty structure, a longitudinal axis1801 of structure 1800 is at a non-zero angle, e.g., perpendicular, withrespect to a longitudinal axis of the annuloplasty structure. Suchintercoiling of coils 1810 with the coils of the coiled compressiblesubunits of the annuloplasty structure facilitates the coupling of theannuloplasty structure with anchoring structure 1800 during thecorkscrewing of structure 1800 into the tissue of the annulus.

For embodiments in which the annuloplasty structure comprises at leastone anchor mount, as described hereinabove, structure 1800 is advancedthrough the anchor mount and into the annulus of the patient.

Reference is now made to FIGS. 5A, 5C, and 12. Typically, head portion1830 has a diameter that is larger than the inner diameter of lumen 501of anchor mount 461. As anchoring structure 1800 is advanced throughlumen 501, a distal surface of head portion 1830 abuts a proximalopening of lumen 501 and inhibits continued distal motion of structure1800 through the tissue of the annulus beyond the predetermined depth.

Reference is now made to FIGS. 8 and 12. Typically, the diameter of headportion 1830 is larger than diameter D2 of channel 460 defined by anchormount 461. As structure 1800 is advanced through channel 460, the distalsurface of head portion 1830 abuts proximal opening 950 and inhibitscontinued distal motion of structure 1800 through the tissue of theannulus beyond the predetermined depth.

Reference is now made to FIGS. 9 and 12. Typically, the diameter of headportion 1830 is larger than the inner diameter of channel 350 coupled toanchor mount 461. As structure 1800 is advanced through channel 350, thedistal surface of head portion 1830 abuts a proximal opening of channel350 and inhibits continued distal motion of coils 1810 through thetissue of the annulus beyond the predetermined distance.

Reference is now made to FIGS. 10 and 12. As structure 1800 is advancedthrough channel 350, the distal surface of head portion 1830 abutshorizontal surfaces 1140 defining aperture 340 and inhibits continueddistal motion of coils 1810 through the tissue of the annulus beyond thepredetermined distance.

Reference is now made to FIGS. 11 and 12. As structure 1800 is advancedthrough channel 1210 of channel 1200, the distal surface of head portion1830 abuts proximal end 1250 of channel 1200 and inhibits continueddistal motion of coils 1810 through the tissue of the annulus.

Reference is again made to FIG. 12. The proximal coil of helical element1802 has a diameter that is larger than the diameter of the distal coilof element 1802. The diameters of the coils of helical element 1802 aregradually reduced in each successive coil from the proximal coil to thedistal coil. The distal coil is corkscrewed into the tissue of theannulus following the puncturing of the annulus by pointed distal end1820. As the distal coil is corkscrewed distally through the tissue ofthe annulus, the distal coil pushes against the surrounding tissue,thereby exerting a radial force against surrounding tissue of theannulus. Each successive proximal coil of helical element 1802 enters anopening defined by the distal coil adjacent thereto. The diameter of theopening is smaller than the diameter of the successive proximal coil.Thus, each successive proximal coil of exerts an outward, radial forceon surrounding tissue corresponding to the diameter of successiveproximal coil. Thus, the proximal coil exerts a greater force on thesurrounding tissue than does the distal coil. It is to be noted that theratio between the diameter of the proximal coil to the diameter of thedistal coil is shown by way of illustration and not limitation. Forexample, the ratio may be smaller than the ratio that appears in FIG.12.

In some embodiments, the proximal coil of helical element 1802 has adiameter that is smaller than the diameter of the distal coil of element1802 (configuration not shown). The diameters of the coils of helicalelement 1802 are gradually increased in each successive coil from theproximal coil to the distal coil. The distal coil is corkscrewed intothe tissue of the annulus following the puncturing of the annulus bypointed distal end 1820. As the distal coil is corkscrewed distallythrough the tissue of the annulus, the distal coil pushes against thesurrounding tissue, thereby exerting a radial force against surroundingtissue of the annulus. Each successive proximal coil of the helicalelement enters an opening defined by the distal coil adjacent thereto.Thus, the frictional force of the cardiac tissue on the anchor isreduced. The diameter of the opening is larger than the diameter of thesuccessive proximal coil. Thus, each successive proximal coil of exertsan inward, radial force on tissue disposed within the lumen of thesuccessive proximal coil corresponding to the diameter of the successivecoil. Thus, the proximal coil exerts a greater force tissue disposedwithin the lumen defined by helical element 1802 than does the distalcoil. Additionally, each coil of helical element 1802 exerts an inward,radial force on tissue disposed within a lumen of helical element 1802corresponding to the diameter of each respective coil.

FIGS. 13A-B show an anchor 1900 comprising a distal barb 1930 and bodyportion 1910 which assume first and second configurations, respectively,in accordance with an embodiment of the present invention. Anchor 1900has a proximal end 1920 and a distal pointed tip 1940 that puncturestissue of the patient. Body portion 1910 is shaped to define a narrowdistal portion 1950 which is proximal to distal barb 1930. Typically,anchor 1900 comprises a shape-memory alloy, e.g., nitinol, which enablesstructure to transition between the configuration shown in FIG. 13A tothe configuration shown in FIG. 13B.

During advancement toward the cardiac tissue, anchor 1900 is typicallysurrounded by an overtube (not shown) which maintains anchor 1900 in agenerally straight configuration (shown in FIG. 13A). A distal end ofthe overtube contacts tissue of the patient and anchor 1900 is slightlypushed distally so that barb 1930 emerges from within the tube and isable to puncture the tissue. Anchor 1900 is further pushed distally fromwithin the overtube such that anchor 1900 further penetrates the tissueand is allowed to gradually assume its resting configuration (i.e., theconfiguration anchor 1900 has a tendency to assume, as shown in FIG.13B) commensurate with the extent of distal pushing of anchor 1900.

For embodiments in which anchor 1900 is used to anchor the annuloplastystructure comprising the braided mesh described hereinabove, anchor 1900is initially passed through the mesh prior to being advanced through thetissue of the patient. In such an embodiment, prior to anchoring theannuloplasty structure to the annulus of the patient, anchor 1900anchors itself to the annuloplasty structure by being entwined by themesh. In some embodiments, prior to being advanced through tissues ofthe annulus, anchor 1900 is advanced through, and in some embodiments,coupled to, anchor mounts 461 described herein.

In some embodiments, as anchor 1900 assumes its bent configuration(shown in FIG. 13B), the proximal bending of body portion 1910 pushesproximally tissue of the annulus that is disposed between anchor 1900and the annuloplasty structure positioned at the surface of the annulus.Thus, annulus tissue is pushed proximally toward the annuloplastystructure. For instances in which a gap is created between theannuloplasty structure and the tissue of the annulus, the proximalpushing of the annulus tissue toward the annuloplasty structure inresponse to the bending of anchor 1900, substantially minimizes oreliminates the gap.

FIGS. 13C-D show anchor 1900 as described hereinabove with reference toFIGS. 13A-B with the exception that body portion 1910 is not shaped toprovide narrow distal portion 1950, in accordance with an embodiment ofthe present invention.

FIG. 13E is a cross-sectional illustration of anchor 1900 anchoredwithin tissue 1960, in accordance with an embodiment of the presentinvention. For embodiments in which anchor 1900 is used in combinationwith an annuloplasty structure, the annuloplasty structure is positionedat a surface 1962 of tissue 1960. In such an embodiment, proximal end1920 is coupled to (e.g., disposed within) the annuloplasty structure ata first location thereof, body portion 1910 of anchor 1900 is disposedwithin tissue 1960 in a “U”-shaped configuration thereof, and distalbarb 1930 is exposed from within tissue 1960 and is coupled to theannuloplasty structure at a second location thereof.

For embodiments in which the annuloplasty structure comprises thebraided mesh, barb 1930 is first passed through the braided mesh at thefirst location of the annuloplasty structure, through tissue 1960, thenthrough the braided mesh at the second location of the annuloplastystructure, thereby anchoring the structure to the annulus whileadditionally coupling anchor 1900 to the annuloplasty structure.

FIGS. 14A-B which are schematic illustrations of an anchor 2000 having asubstantially rigid body portion 2010, a distal pointed tip 2032, and aflap 2050 proximal to distal tip 2032 which assume first and secondpositions, respectively, in accordance with an embodiment of the presentinvention. Body portion 2010 has a proximal end 2020 and is shaped todefine a slit 2040 between a distal portion of body portion 2010 andflap 2050. Slit 2040 enables flap 2050 to transition between theconfiguration of flap 2050 shown in FIG. 14A to the configuration offlap 2050 shown in FIG. 14B. Typically, anchor 2000 comprises ashape-memory alloy, e.g., nitinol, which enables flap 2050 to transitionalong a junction 2030 between flap 2050 and body portion 2010 betweenthe configuration shown in FIG. 14A to its resting configuration (i.e.,the configuration flap has a tendency to assume, as shown in FIG. 14B).

Anchor 2000 is typically surrounded by a sheath or sleeve (not shown)that is typically rectangular and defines a lumen for surrounding anchor2000, and enables flap 2050 to maintain a generally straightconfiguration (shown in FIG. 14A) as it is advanced toward the tissue ofthe patient. A distal end of the sheath contacts tissue of the patientand anchor 2000 is slightly pushed distally so that distal pointed tip2032 emerges from within the tube and is able to puncture the tissue.Anchor 2000 is further pushed distally from within the overtube suchthat anchor 2000 further penetrates the tissue. Structure is thendistally advanced to a desired depth and is then pulled proximallyenabling flap 2050 to gradually bend along junction 2030 away from alongitudinal axis of body portion 2010. Anchor 2000 assumes its relaxed,or bent, position (shown in FIG. 14B) commensurate with the extent ofproximal pulling of anchor 2000. A proximal end of flap 2050 is shapedto define a pointed tip 2052. As flap 2050 assumes its relaxed, or bent,configuration, tip 2052 punctures surrounding tissue in order to furtheranchor anchor 2000 to tissue of the patient. In its relaxed, or bent,configuration, flap 2050 defines a surface 2051 that is alignedangularly with respect to the longitudinal axis of body portion 2010.Surface 2051 defined by flap 2050 is configured to restrict furtherproximal motion of anchor 2000.

For embodiments in which anchor 2000 is used to anchor the annuloplastystructure comprising the braided mesh described hereinabove, the sheathor sleeve surrounding anchor 2000 is initially passed through the mesh.In some embodiments, prior to being advanced through tissues of theannulus, anchor 2000 is advanced through, and in some embodiments,coupled to, anchor mounts 461 described herein. For embodiments in whichanchor 2000 is advanced through anchor mounts 461, the channel providedby the anchor mount functions to maintain the generally straightenedconfiguration as structure is advanced through the anchor mount towardthe tissue of the annulus.

FIG. 15 shows an anchor 2100 having a proximal end 2120, a substantiallyrigid, cylindrical body portion 2110, and a distal end 2130 shaped todefine distal prongs 2140 each having pointed distal end 2142, inaccordance with an embodiment of the present invention. Each prong 2140is shaped to define a tapered body portion and a distal barb 2150 shapedto define distal pointed end 2142 and proximal pointed ends 2152.Typically, anchor 2100 comprises a shape-memory alloy, e.g., nitinol,which enables prongs 2140 to transition from the substantially straightconfiguration, as shown, to a curved configuration in which pointeddistal ends 2142 curve proximally such each prong 2140 assumes asubstantially “U”-shaped configuration. It is to be noted that anchor2100 is shown as comprising three prongs 2140 by way of illustration andnot limitation, and that any suitable number or prongs may be used.

During advancement toward the cardiac tissue, anchor 2100 is typicallysurrounded by an overtube (not shown) which maintains prongs 2140 in agenerally straight configuration (as shown). A distal end of theovertube contacts tissue of the patient and anchor 2100 is slightlypushed distally so that distal pointed ends 2142 emerge from within thetube and puncture the tissue. Anchor 2100 is further pushed distallyfrom within the overtube such that anchor 2100 further penetrates thetissue and prongs 2140 are allowed to gradually bend away from alongitudinal axis of body portion 2110 in order to assume theirrespective bent configurations (shown in FIG. 16B) commensurate with theextent of distal pushing of anchor 2100. As prongs 2140 assume theirrespective bent configurations, proximal pointed ends 2152 puncturesurrounding tissue in order to further anchor anchor 2100 to tissue ofthe patient. In its expanded, bent configuration, anchor 2100 isconfigured to restrict proximal motion of anchor 2100 through thetissue.

For embodiments in which anchor 2100 is used to anchor the annuloplastystructure comprising the braided mesh described hereinabove, theovertube is initially passed through the mesh until it contacts cardiactissue underlying the annuloplasty structure. In such an embodiment,prior to anchoring the annuloplasty structure to the annulus of thepatient anchor 2100 is anchored to the annuloplasty structure by beingentwined in the braided mesh. Once the distal end of the overtubecontacts tissue of the annulus, anchor 2100 is pushed distally fromwithin the overtube and into tissue of the annulus. In some embodiments,prior to being advanced through tissues of the annulus, anchor 2100 isadvanced through, and in some embodiments, coupled to, anchor mounts 461described herein.

For embodiments in which anchor 2100 is advanced through anchor mounts461 described herein, the channel provided by the anchor mount functionsto maintain the generally straightened configuration as anchor 2100 isadvanced through the anchor mount toward the tissue of the annulus.

In some embodiments, as prongs 2140 of anchor 2100 assume theirrespective bent configurations (shown in FIG. 16B), the proximal bendingof prongs 2140 pushes proximally tissue of the annulus that is disposedbetween anchor 2100 and the annuloplasty structure. Thus, annulus tissueis pushed proximally toward the annuloplasty structure. For instances inwhich a gap is created between the annuloplasty structure and the tissueof the annulus, the proximal pushing of the annulus tissue toward theannuloplasty structure in response to the bending of prongs 2140 ofanchor 2100, substantially minimizes or eliminates the gap.

Anchor 2100 is shaped to define an opening 2160 in a vicinity ofproximal end 2120 of anchor 2100. Typically, an anchoring advancementdevice, an advancement tube, and advancement rod, or a suture, isremovably coupled to anchor 2100 by being looped through opening 2160.

It is to be noted that anchor 2100 is shaped to define opening 2160 byway of illustration and not limitation. For example, anchor 2100 may bemanufactured without opening 2160. For either embodiment in which anchor2100 is shaped to define opening 2160 or in which anchor 2100 is notshaped to define opening 2160, an anchor advancement structure, asdescribed herein, may be coupled to anchor 2100 via a lumen defined bycylindrical body portion 2110 of anchor 2100.

FIGS. 16A-B show an anchor delivery system 2200 comprising stationaryfinger-engaging rings 2220, a displaceable finger-engaging ring 2222,and a tubular housing 2210 configured to advance and facilitateanchoring of anchor 2100, in accordance with an embodiment of thepresent invention. System 2200 comprises a pushing rod 2224 which iscoupled at a distal end thereof to displaceable finer-engaging ring 2222and is slidably displaced through tubular housing 2210. A distal end ofpushing rod 2224 is coupled to a proximal end of a secondary pushing rod2226 which is configured to slide within a lumen defined by a distaltubular element 2228.

Typically, one or more anchors 2100 are preloaded within distal tubularelement 2228. In response to distal displacement of ring 2222, pushingrod 2224 applies a force to secondary pushing rod 2226, which in turnslides in part within element 2228 and applies a force to the at leastone anchor 2100 disposed therein. In response to the applied force,anchor 2100 is pushed from within element 2228, and ultimately distallyto a distal end 2230 of element 2228. As it is pushed, anchor 2100 isadvanced into tissue of the patient, as described hereinabove withreference to FIG. 15.

In some embodiments, distal tubular element 2228 may be attachable torod 2226 by being slidable around a distal portion of rod 2226. In suchan embodiment, one or more anchors are preloaded within tubular element2228 and subsequently, element 2228 is slid around the distal portion ofrod 2226.

As shown in FIG. 16A, anchor 2100 is preloaded within tubular element2228 of system 2200 in a compressed state thereof. A proximal end ofanchor 2100 is coupled to a cap 2170 comprising at least one expandableprojection 2172 which is compressed within tubular element 2228. Whenanchor 2100 is expanded (shown in FIG. 16B), projections 2172 impedecontinued distal advancement of anchor 2100 within tissue of the patientbeyond a predetermined depth that is defined by the combined height ofanchor 2100 and a portion of cap 2170 between a distal end thereof and adistal end of projection 2172 in an expanded state thereof.

FIG. 16B shows ring 2222 pushed distally, as indicated by the arrow. Alength of an exposed portion of secondary pushing rod 2226 is shorterthan the length of the exposed portion of rod 2226, as shown in FIG.16A, indicating that a distal portion of rod 2226 has been pushed withintubular element 2228, which thereby pushes anchor 2100 distally fromwithin tubular element 2228. Once exposed from within element 2228,anchor 2100 is allowed to assume its relaxed, predeterminedconfiguration, as shown in FIG. 16B, in which prongs 2140 are allowed tocurl proximally, as described hereinabove with reference to FIG. 15.Additionally, projections 2172 are allowed to assume their respectiverelaxed configurations, in which projections 2172 project laterally fromcap 2170.

In some embodiments, in response to continued pushing of ring 2222, adistal portion of ring 2222 abuts a proximal portion of tubular housing2210 and impedes continued distal motion of rod 2226.

Typically, system 2200 is used during an open-heart procedure in orderto anchor an annuloplasty device to the annulus of the patient. Forembodiments in which the annuloplasty structure comprises a braided meshas described herein, distal end 2230 of system 2200 is advanced throughthe braided mesh until it abuts against the lateral surface of theannuloplasty structure, i.e., the surface with is in contact with theannulus. Distal displacement of ring 2222 advances the at least oneanchor 2100 distally to distal end 2230 of system 2200, through aportion of the braided mesh, and subsequently into tissue of thepatient. Anchor 2100 is coupled to the braided mesh when projections2172 engage, e.g., are entangled with, at least a portion of the mesh.

For embodiments in which the annuloplasty structure comprises at leastone anchor mount, as described herein, distal end 2230 of system 2200may be advanced at least in part through the anchor mount. Ring 2222 isdistally displaced and anchor 2100 is advanced distally to distal end2230 of system 2200 through the channel of the anchor mount, andsubsequently into tissue of the patient. As the anchor is advancedthrough the channel of the mount, the wall defining the channelmaintains the straight configuration of the anchor. As cap 2170 isadvanced distally, and projections 2172 emerge from within tubularelement 2228, projections 2172 expand. Typically, a diameter defined byexpanded projections 2172 is larger than the diameter of the channel ofthe anchor mount. As such, the distal ends of projections 2172 abutagainst the proximal opening of the channel and impede continued distaladvancement of the anchor through the tissue of the patient.

For embodiments in which a plurality of anchors are housed withintubular element 2228, system 2200 comprises a baffle mechanism or aratchet mechanism in order to ensure that distal displacement of ring2222 will advance only one anchor at a time out of tubular element 2228.

It is to be noted that the scope of the present invention includes useof system 2200 for advancement and anchoring of any of the anchors oranchoring structures described herein. For embodiments in which system2200 is used in order to anchor the helical anchors described herein,system 2200 may be rotated along a longitudinal axis of housing 2210.

Reference is now made to FIGS. 17A-F, which are schematic illustrationsof a system 400 for repairing a mitral valve 30, being advanced into aleft atrium of a patient, in accordance with an embodiment of thepresent invention. Typically, a catheter 404 (FIG. 17B) is advanced intothe left atrium of the patient using a percutaneous endovascularapproach typically combined with monitoring by electromagnetic and/orsound waves, e.g., fluoroscopy, transesophageal echo, transthoracicecho, and/or echocardiography, to maintain real-time orientation of adistal tip of the catheter within the heart of the patient. Typically,catheter 404 is transseptally advanced into the left atrium.

Catheter 404 typically comprises a 13 F catheter, although another sizemay be appropriate for a given patient. In some embodiments, catheter404 is advanced through vasculature of the patient and into the rightatrium using a suitable point of origin typically determined for a givenpatient. For example:

(1) Catheter 404 is introduced into the femoral vein of the patient,through the inferior vena cava, into the right atrium of the heart,transseptally, e.g., typically, through the fossa ovalis, and finallyinto the left atrium;

(2) Catheter 404 is introduced into the basilic vein, through thesubclavian vein to the superior vena cava, into the right atrium,transseptally, e.g., typically, through the fossa ovalis, and finallyinto the left atrium; or

(3) Catheter 404 is introduced into the external jugular vein, throughthe subclavian vein to the superior vena cava, into the right atrium,transseptally, e.g., typically, through the fossa ovalis, and finallyinto the left atrium.

In some embodiments, catheter 404 is advanced through an inferior venacava 22 of the patient (as shown) and into the right atrium using asuitable point of origin typically determined for a given patient.

FIG. 17A shows a guide wire 402 being advanced into the right atrium ofthe patient. Advancement of wire 402 typically precedes advancement ofcatheter 404 into the right atrium of the patient. Wire 402 comprises asemi-rigid wire which provides a guide for the subsequent advancement ofcatheter 404 therealong and into the right atrium of the patient, asshown in FIG. 17B. Once catheter 404 has entered the right atrium, guidewire 402 is retracted and extracted from within the body of the patient(FIG. 17C). In FIG. 17D, catheter 404 is pushed distally until itreaches the interatrial septum of heart 20 of the patient.

(In this context, in the specification and in the claims, “proximal”means closer to the orifice through which catheter 404 is originallyplaced into the vasculature of the patient, and “distal” means furtherfrom this orifice.)

As shown in FIG. 17E, a resilient needle 406 and a dilator (not shown)are advanced through catheter 404 and into heart 20 of the patient. Inorder to advance catheter 404 transseptally into the left atrium, thedilator is advanced to the septum, and the needle 406 is pushed fromwithin the dilator and is allowed to puncture the septum of heart 20such that an opening is created which facilitates passage of the dilatorand subsequently catheter 404 therethrough and into the left atrium.Subsequently, the dilator is through the hole in the septum of heart 20created by needle 406. Typically, the dilator is shaped to define ahollow shaft for passage along needle 406, the hollow shaft being shapedto define a tapered distal end. This tapered distal end is firstadvanced through the hole created by needle 406. The hole is enlargedwhen the gradually increasing diameter of the distal end of the dilatoris pushed through the hole in the septum. The advancement of catheter404 through the septum and into the left atrium is followed by theextraction of the dilator and needle 406 from within catheter 404 (FIG.17F).

FIG. 17G is a schematic illustration of a first discrete segment 430 anda second discrete segment 440 of an annuloplasty structure 408, e.g., atleast one elongate segment, typically two as shown, being advanced alongcatheter 404, in accordance with an embodiment of the present invention.Segments 430 and 440 are disposed within catheter 404 in a substantiallylinear configuration, thereby having a longitudinal axis thereof.Segments 430 and 440 are configured to be chronically implanted withinheart 20 along an annulus 40 of mitral valve 30. Typically, segments 430and 440 comprise a biocompatible material, e.g., ePTFE, PTFE, nitinol,stainless steel, platinum iridium, titanium, or cobalt chrome. In someembodiments, segments 430 and 440 are coated with PTFE(Polytetrafluoroethylene). Compressible subunits 450 are illustrated ascoils, by way of illustration and not limitation, and facilitate bendingof the segments into a suitable configuration and compressing of thesegments when they are later drawn toward one another. For example,compressible subunits 450 may be shaped as struts of a stent, as abellows, or as an accordion, or may comprise a braided mesh (as shown inFIG. 1). In some embodiments, a braided mesh comprising an elasticmaterial, e.g., metal or fabric such as polyester, surrounds segments430 and 440.

In some embodiments of the present invention, segments 430 and 440comprise coils made of stainless steel, e.g., type 316 LVM. Suitablecoil shapes include round wire coils or flat wire coils.

It is to be noted that any one of ratchet mechanisms (e.g., ratchetmechanism 200, ratchet mechanism 600, or tubular ratchet mechanism 3101)described herein may be disposed within the longitudinal lumen ofstructure 408.

Prior to advancing segments 430 and 440 into the left atrium of thepatient, segments 430 and 440 are loaded into an advancement catheter410 in a substantially linear configuration, as shown in FIG. 17G. Thelinear configuration defines a longitudinal axis of segments 430 and 440of structure 408. Segments 430 and 440 are typically advanced into theleft atrium of the patient during a single transcatheter advancement.

During advancement of segment 430 within advancement catheter 410,segment 430 has a length L1 between about 20 mm and about 60 mm, e.g.,30 mm. Typically, segment 430 is configured for positioning along aportion of annulus 40 at the junction between annulus 40 and the base ofthe anteromedial leaflet of valve 30. Similarly, second segment 440 isdesignated to be anchored to annulus 40 at the base of theposterolateral leaflet, and thus is sized in accordance therewith. Forexample, segment 440 may have a length L2 of between about 30 mm andabout 100 mm, e.g., 50 mm. The respective lengths of segments 430 and440 enable the segments to dynamically support the mitral valve inaccordance with the relative motion of the anteromedial andposterolateral leaflets. Typically, segments 430 and 440 each have adiameter L3 of between about 2.0 mm and about 4.0 mm, typically betweenabout 2.5 mm and about 3.5 mm.

Typically, segments 430 and 440 are each shaped to define a lateral wallthat has at least one flexible hollow lumen configured for slidingadvancement of at least one control wire therethrough. As shown, a firstcontrol wire 480 and a second control wire 490 are disposed within boththe first and second segments 430 and 440. Typically, wires 480 and 490function to position and adjust a relative disposition and configurationof segments 430 and 440 with respect to a configuration of annulus 40 ofvalve 30. Such functions of wires 480 and 490 are described hereinbelow.As such, a diameter of control wires 480 and 490 (e.g., between about0.2 mm and about 0.4 mm, typically, between 0.25 mm and 0.3 mm) providesthe wires with the strength to control structure 408. Typically, controlwires 480 and 490 provide a pulling and/or pushing force to segments 430and 440.

Control wires 480 and 490 comprise a flexible, resilient, andsuperelastic material, e.g., nitinol, polyester, ePTFE, stainless steel,or cobalt chrome, and are configured to reside chronically withinstructure 100. In some embodiments, control wires 480 and 490 comprise abraided polyester suture (e.g., Ticron). In some embodiments, controlwires 480 and 490 are coated with polytetrafluoroethylene (PTFE). Insome embodiments, control wires 480 and 490 each comprise a plurality ofwires that are intertwined to form a rope structure.

In some embodiments, first and second control tubes are disposed withinboth the first and second segments. Typically, the first and secondcontrol tubes are configured to function similarly to control wires 480and 490 described herein.

Typically, each segment 430 and 440 comprises a plurality ofcompressible subunits 450 and a plurality of anchor mounts 461 which aredisposed alternately with respect to one another. It is to be noted,however, that segments 430 and 440 may each comprise a single elongatestructure comprising compressible material and do not comprise anchormounts 461.

Typically, each anchor mount 461 is shaped to define a lateral wall thatis shaped to provide a first portion 464 and a second portion 466generally at opposite sites of mount 461 when viewed in cross-section(e.g., at 12 o'clock and 6 o'clock). Anchor mounts 461 of annuloplastystructure 408 each comprise at least one channel 460. Channel 460 isconfigured to extend from first portion 464, through the given segment,to second portion 466. A respective flexible and longitudinal guidemember 470 is coupled, e.g., welded, looped through, or soldered, at adistal end thereof to a portion of lateral wall 462 of mount 461 and isused to facilitate anchoring of annuloplasty structure 408 to theannulus of the patient, as will be described hereinbelow.

It is to be noted that although anchor mount 461 is shaped to definechannel 460 by way of illustration and not limitation. For example,anchor mount 461 may comprise any one of the anchor mounts describedherein with reference to FIGS. 1, 3, 4, 5A, 5C, 8, 9, and 10. It is tobe noted that a respective anchor channel 1200 described in FIG. 11 maybe used in combination with one or more anchor mounts 461.

Typically, guide member 470 is configured to facilitate guiding of ananchoring system toward channel 460 (as will be described hereinbelow).Typically, guide member 470 comprises a flexible, superelastic metalwire, e.g., nitinol or PTFE. In some embodiments, guide member 470comprises a fiber, e.g., nylon, polypropylene, Kevlar, Teflon, orpolyester. Typically, each guide member 470 has a diameter of betweenabout 0.05 mm and about 0.3 mm, e.g., 0.1 mm. Prior to advancingsegments 430 and 440 into the left atrium of the patient, advancementcatheter 410 is preloaded with segments 430 and 440, with control wires480 and 490, with guide members 470, and with a multilumen catheter 420which is disposed proximally to segments 430 and 440. Thus, segments 430and 440 are simultaneously conveyed toward heart 20, during a singletranscatheter advancement. Typically, advancement catheter 410 comprisesa 12 F catheter, although other sizes may be appropriate depending onthe size of catheter 404.

In some embodiments of the present invention, multilumen catheter 420 isshaped to provide a primary lumen and at least one secondary lumen.Typically, multilumen catheter 420 is configured to advance therethroughand into the left atrium an anchor coupled to an anchor-advancementstructure, e.g., a tube or a rod. In some embodiments, the multilumencatheter is disposed proximally to the annuloplasty structure and isconfigured to push the segments through the advancement catheter.

FIGS. 17H-I show deployment of first segment 430 of the segmentedannuloplasty ring, in accordance with an embodiment of the presentinvention. Segments 430 and 440 are disposed in a linear configurationwithin advancement catheter 410 when catheter 410 is advanced withincatheter 404 and initially enters the left atrium. As shown in FIG. 17H,a distal end of catheter 410 emerges from within catheter 404. Segment430 maintains its linear configuration as it is initially pushed fromwithin catheter 410.

Anchor mount 461 is coupled to a bar 710, as described hereinabove withreference to FIG. 11. It is to be noted that anchor mount 461 is coupledto bar 710 by way of illustration and not limitation. For example,anchor mount 461 may not be coupled to bar 710, as describedhereinabove. Typically, bar 710 is disposed within channel 460angularly, e.g., substantially perpendicular, with respect to an axis477 (as shown in FIG. 17G) of channel 460, i.e., the axis that istransverse with respect to the longitudinal axis of structure 408, andsubstantially parallel to the longitudinal axis of annuloplastystructure 408.

Typically, first and second segments 430 and 440 of structure 408 areultimately made to assume a somewhat round configuration that resemblesan annuloplasty ring in structure and function.

As shown in FIG. 17I, control wires 480 and 490 are tightly pulledproximally, applying a force to segment 430 and compressing segment 430so that it is made to assume a curved configuration. The curvedconfiguration is thus achieved as compressible subunits 450 arecompressed in response to the pulling of control wires 480 and 490.Typically, compressible subunits 450 are compressed generally inparallel with the longitudinal axis of segment 430. Such a curvedconfiguration minimizes the possibility for segment 430 to prematurelycontact walls of heart 20: (1) during deployment of system 400 withinthe left atrium, and (2) prior to positioning segments 430 and 440 alongannulus 40.

It is to be noted that in some embodiments, segments 430 and 440 ofannuloplasty structure 408 comprise a shape-memory alloy, e.g., nitinol.In some embodiments, segments 430 and 440 are introduced within catheter410 in a straight configuration, and are each biased to assume agenerally semi-circular configuration once expanded from within catheter410. Annuloplasty structure 408 thus assumes a somewhat roundconfiguration typically independently of the application of a proximalforce to control wires 480 and 490. In such an embodiment, control wires480 and 490 are used instead to expand the segments by separating atleast a part of segment 430 from at least a part of segment 440.

FIG. 17J is a schematic illustration of system 400 comprisingannuloplasty structure 408 and multilumen catheter 420, in accordancewith an embodiment of the present invention. Each control wire 480 and490 is coupled to a respective adjustment wire 482 and 492 by way ofillustration and not limitation. Adjustment wires 482 and 492 areconfigured to contribute to adjusting a relative disposition of segments430 and 440 once inside the left atrium of heart 20. The functions ofwires 482 and 492 are described in more detail hereinbelow.

Typically, multilumen catheter 420 is shaped to define a primary lumen426 and secondary lumens 422 and 424. The distal end of each guidemember 470 is coupled to a respective anchor mount 461 and the proximalend of each guide member 470 is manipulated or controlled from outsidethe body of the patient proximally to catheter 410, while a majority ofthe remaining portion of guide member 470 (i.e., the portion of guidemember 470 disposed between the proximal and distal ends thereof) isdisposed within primary lumen 426.

In some embodiments, multilumen catheter 420 comprises a plurality ofsecondary lumens for passage of guide members 470 therethrough. In someembodiments, multilumen catheter 420 provides a respective lumen foreach guide member 470. In such an embodiment, catheter 420 preventstangling of guide members 470 as they are disposed therein. In someembodiments, two or more guide members 470 may be disposed within asingle secondary lumen of multilumen catheter 420.

In some embodiments, a handle assembly (not shown) is coupled to aproximal end of catheter 410. The handle assembly may be disposable.Respective proximal ends of guide members 470 are accessible andcontrollable from the handle assembly. For example, a respectiveproximal end of each guide member 470 may be coupled to a respectiveswitch which independently controls the guide member. Additionally,respective ends of control wires 480 and 490 are accessible andcontrollable from the handle assembly. Further additionally, a proximalend of lumen 426 and of catheter 421 disposed therein are accessiblefrom the handle assembly in order to advance an anchor through catheter421 and toward the annuloplasty structure (as will be describedhereinbelow).

Each guide member 470 is reversibly coupled to a flexible, steerablecatheter 421 which is disposed within primary lumen 426 of multilumencatheter 420. In some embodiments, a distal portion of each guide member470 is disposed alongside an external surface of at least a portion,e.g., a distal portion, of catheter 421, e.g., typically, when catheter421 is pushed distally from within multilumen catheter 420. Catheter 421is steerable by guide members 470 in response to a pulling force appliedto a respective one of guide members 470 (as will be describedhereinbelow). Catheter 421 is shaped to define a lumen configured forpassage therethrough of an anchor coupled to an anchor advancementsystem. Catheter 421 is typically steered toward a given anchor mount461 in response to the pulling of a given guide member 470 attachedthereto. Catheter 421 comprises a tapered distal end 429 which ispositioned within channel 460 of anchor mount 461. Once end 429 ispositioned within channel 460, the anchor disposed within catheter 421is advanced therefrom distally toward the annulus. Since, a respectiveanchor or anchoring structure is advanced through the lumen of catheter421, the lumen of catheter 421 typically has a diameter D7 of betweenabout 1.0 mm to about 4.0 mm (e.g., 2.0 mm). Diameter D7 of catheter 421allows passage therethrough of at least one anchor at a given time.

Typically, once segments 430 and 440 are initially pushed from withincatheter 410, and prior to pushing of steerable catheter 421 from withinmultilumen catheter 420, one or more guide members 470 functions toposition and adjust a relative disposition and configuration of segments430 and 440 with respect to a configuration of annulus 40 of valve 30.For example, pulling on one or more guide members 470 may liftproximally from the annulus a portion of the segment to which it iscoupled, while the remaining portions of the segment are disposed in aspatial orientation that is distal with respect to the portion of thesegment being raised.

Typically, in order to accommodate for the combined diameters ofcatheter 421 and the plurality of guide members 470, primary lumen 426of multilumen catheter 420 has a diameter D1 of between 1.2 mm and 4.5mm, e.g., 2.5 mm.

Catheter 421 comprises an external ring 427 disposed proximally todistal end 429 and facilitates coupling of respective distal portions ofguide members 470 to the external surface of catheter 421. As shown inthe cross-section of ring 427, ring 427 is shaped to define a pluralityof lumens 431 for passage therethrough of a respective one of guidemembers 470. In such an embodiment, guide members 470 are prevented frombeing tangled together. In some embodiments, two or more guide members470 pass through a single lumen 431. In such an embodiment, lumen 431may be circular, oval, or any other suitable shape. It is to be notedthat the size and shape of lumen 431 are shown by way of illustrationand not limitation and that the size and shape of lumens 431 may belarger than they appear in FIG. 17J. Typically, ring 427 is allowed torotate with respect to the longitudinal axis of catheter 421. Suchfreedom of movement of ring 427 with respect to catheter 421 facilitatesunobstructed steering of catheter 421 in response to pulling of a givenlongitudinal guide member 470. Additionally, the freedom of movementreduces any resistance in pulling of the given guide member 470.

First and second portions of control wire 490 and a portion ofadjustment wire 482 are disposed within secondary lumen 422 (as shown)of multilumen catheter 420, while first and second portions of controlwire 480 and a portion of adjustment wire 492 are disposed withinsecondary lumen 424 (as shown) of multilumen catheter 420. Multilumencatheter 420 separates and isolates control wire 480 from control wire490 and separates and isolates adjustment wire 482 from adjustment wire492, thereby enabling the physician to distinguish between each ofcontrol wires 480 and 490 and between adjustment wires 482 and 492.Thus, catheter 420 helps facilitate independent control by the physicianof each of the wires which ultimately determine the relative positioningof structure 408 within the left atrium of heart 20.

In some embodiments, control wires 480 and 490 and adjustment wires 482and 492 may be disposed within in the same secondary lumen of multilumencatheter 420 and are coupled to the handle (described hereinabove) insuch a manner so as to prevent tangling and to allow proper control ofeach of the wires.

Typically, steerable catheter 421 pushes segments 430 and 440 distallywithin advancement catheter 410.

FIGS. 18A-B are schematic perspective views of system 400 comprisingannuloplasty structure 408 which is coupled to annulus 40 of mitralvalve 30, in accordance with an embodiment of the present invention. Asshown, guide members 470 are coupled at respective distal ends thereofto respective anchor mounts 461 of annuloplasty structure 408.Respective portions of guide members 470 pass through ring 427 andalongside catheter 421, and ultimately through advancement catheter 410.As shown, advancement catheter 410 comprises a radiopaque marking 411 ata distal portion thereof, and marking 411 helps the physician locate thedistal end of catheter 410 with respect to structure 408. In someembodiments, and during initial positioning of the distal end ofadvancement catheter 410 within the left atrium of heart 20, at leastone steering wire 413, e.g., one as shown, is coupled at a distal endthereof to a distal portion of catheter 410. A proximal end of steeringwire 413 is disposed at a site outside the body of the patient, enablingthe physician to steer the distal end of catheter 410.

Control wires 480 and 490 are shown disposed within at least one hollowlumen of both first and second segments 430 and 440 of annuloplastystructure 408, thereby coupling the segments. In some embodiments, eachof segments 430 and 440 is shaped to provide a first lumen configuredfor sliding advancement therethrough of wire 480, and a second lumenconfigured for sliding advancement of wire 490 (configuration notshown). First and second portions of control wire 480 emerge from withinsegments 430 and 440 at respective first ends 432 and 442 of segments430 and 440. The first and second portions of control wire 480 aredisposed within secondary lumen 424 of multilumen catheter 420 such thatfirst and second ends of wire 480 are exposed and controllable fromoutside the body of the patient. Similarly, first and second portions ofcontrol wire 490 emerge from within segments 430 and 440 at respectivesecond ends 434 and 444 of segment 430 and 440. The first and secondportions of control wire 490 are disposed within secondary lumen 422 ofmultilumen catheter 420, such that first and second ends of wire 490 areexposed and controllable from outside the body of the patient.

In some embodiments, multilumen catheter 420 is shaped to provideadditional secondary lumens (not shown for clarity of illustration).Typically, the additional secondary lumens are provided for passage ofsupplementary instruments, e.g., for suction and/or irrigation,therethrough and into the left atrium of the patient.

Following the deployment, segments 430 and 440 are expanded by beingseparated in accordance with the shape of the dilated annulus. In someembodiments, adjustment wires 482 and 492, shown in FIG. 17J, helpfacilitate the separation of segments 430 and 440. Techniques for usewith annuloplasty structure 408 and adjustment wires (referred tohereinabove as 482 and 492) may be used in combination with techniquesdescribed in U.S. Provisional Application 61/001,013 to Gross et al.,entitled, “Segmented ring placement,” filed Oct. 29, 2007.

The separating of segments 430 and 440 occurs when the physician pushescontrol wires 480 and 490. In some embodiments, during the pushing ofcontrol wires 480 and 490, the physician simultaneously pushes whilepushing the adjustment wires which provide an auxiliary pushing forcewhich helps expand segments 430 and 440. Such pushing of the controlwires feeds greater portions of control wires 480 and 490 into segments430 and 440. The relaxed configuration of control wires 480 and 490 isshown in FIGS. 18A-B. Typically, segments 430 and 440 expand laterallyas increasing lengths of control wires 480 and 490 are pushed and fedinto segments 430 and 440.

Control wires 480 and 490 enable the physician to independently controla relative disposition of second ends 434 and 444 and first ends 432 and442 of segments 430 and 440, respectively. For example, distal pushingof the first and second ends of control wire 480 distances second ends434 and 444 of segments 430 and 440, respectively. Similarly, distalpushing of the first and second ends of control wire 490 distances firstends 432 and 442 of segments 430 and 440, respectively. It is to benoted that the use of two discrete control wires allows for independentcontrol of the distance that separates first ends 432 and 442 and thedistance that separates second ends 434 and 444 of segments 430 and 440.

Additionally, pulling on respective ends of control wires 480 and 490shapes segments 430 and 440 in accordance with the curved structuralconformation of annulus 40 at a given site destined for anchoring of arespective one of the segments thereto. For example, pulling on a firstend of control wire 490 and on a first end of control wire 480 curvessegment 430 by drawing together second end 432 and first end 434,respectively, of segment 430. Thus, segment 430 is compressed at leastin part, and is made to assume a shape according to the curvature of theannulus at the base of the anteromedial leaflet.

In some embodiments of the present invention, structure 408 isoptionally rotated as appropriate about an axis of annulus 40. Guided byfluoroscopy and/or echocardiography, the physician assesses the relativedisposition of segments 430 and 440 with respect to annulus 40 of heart20. Multilumen catheter 420 is configured to be rotatable 360 degreesabout a longitudinal axis thereof. By rotating multilumen catheter 420,the segments are positioned properly with respect to the annulus. Thatis, segment 440 is positioned above a portion of annulus 40 at the baseof the posterolateral leaflet, while segment 430 is positioned above aportion of annulus 40 at the base of the anteromedial leaflet.

Following the deployment and expansion of annuloplasty structure 408,catheter 421 is pushed distally from within advancement catheter 410,thereby exposing a distal end of steerable catheter 421. Additionally,in some embodiments, multilumen catheter 420 is retracted slightlywithin advancement catheter 410. Retracting multilumen catheter 420frees the lumen of the distal end of catheter 410, thereby restoringflexibility to the distal end of catheter 410 and enabling propersteering thereof, e.g., in response to pulling steering wire 413.Structure 408 is pushed toward annulus 40 by pushing on both catheter410 and on wires 480 and 490. Additionally, the structure is properlyaligned with annulus 40 by steering and/or rotating the distal tip ofcatheter 410, and by steering and/or rotating the distal tip ofmultilumen catheter 420.

As shown, segment 440 is aligned against the base of posterolateralleaflet 32 at the annulus, and segment 430 is aligned against the baseof anteromedial leaflet 34 at the annulus. Segments 430 and 440 areshown prior to anchoring thereof to annulus 40.

Reference is now made to FIG. 19A, which is a schematic illustration ofcatheter 421 of system 400 being steered toward a given anchor mount 461of structure 408 and facilitating anchoring of structure 408 to annulus40, in accordance with an embodiment of the present invention.

Once advancement catheter 410 and multilumen catheter 420 havepositioned segments 430 and 440 in their proper orientation with respectto annulus 40, steerable catheter 421 is pushed from within advancementcatheter 410, thereby exposing a distal portion of steerable catheter421. The physician pulls on the proximal end of a first guide member 472of the plurality of guide members 470. In response to the pulling,catheter 421 is steered toward the distal end of guide member 472, andthereby toward segment 440 and toward an anchor mount 461 which iscoupled to the distal end of guide member 472. As the physician pullsthe proximal end of guide member 472, he releases the respectiveproximal ends of guide members 470 not being pulled in order to provideslack to members 470 such that they do not resist movement of catheter421 toward anchor mount 461. In conjunction with the steering ofcatheter 421, the physician pushes on a proximal end of catheter 421 soas to push catheter 421 distally toward the location along segment 440to which it is being steered. As the distal end of catheter 421 issteered toward anchor mount 461, portions of members 470 that arecoupled to ring 427 of catheter 421 are also drawn toward anchor mount461. When the distal end of catheter 421 has been sufficiently steeredtoward anchor mount 461, catheter 421 is further pushed distally suchthat distal tapered end 429 of catheter 421 slides partially withinchannel 460 of anchor mount 461.

At a site proximal to catheter 404, and outside the body of the patient,the physician slides a first anchoring system through the lumen ofcatheter 421. The anchor is advanced via the anchoring system throughthe lumen of catheter 421 toward structure 408, through a lumen ofdistal tapered end 429, and subsequently inserted, in part, into channel460 of anchor mount 461. For embodiments in which catheter 410 iscoupled to the handle assembly, as described hereinabove, the anchor isintroduced within the lumen of catheter 421 from a proximal openingwithin the handle which provides an access to the lumen of catheter 421.In some embodiments, the handle comprises a hemostatic valve at theopening. The anchor of the anchoring system is ultimately furtheradvanced through tissue of annulus 40. As shown, the anchor of theanchoring system comprises a helical anchor 740 having a pointed distaltip 750 configured to puncture tissue of annulus 40. Anchor 740 iscorkscrewed into tissue of annulus 40. It is to be noted that helicalanchor 740 is shown by way of illustration and not limitation. Forexample, any anchor described herein as well as any suitable tissueanchor known in the art may be passed through the lumen of catheter 421and used to anchor structure 408 to annulus 40 of mitral valve 30.

FIG. 19B shows catheter 421 being advanced toward anchor mount 461 ofsegment 440, in accordance with an embodiment of the present invention.Guide member 472 is pulled such that it is made taught and enablessteering of catheter 421 toward anchor mount 461 to which guide member472 is coupled. Guide members 470 that are not being pulled are shown asbeing in a relaxed, passive, slackened state. Typically, at least adistal portion of catheter 421 comprises a plurality of compressiblesubunits, e.g., accordion- or bellow-shaped structures, a braided mesh,or a plurality of coils, which enable steering and maneuvering ofcatheter 421 in the direction of the guide member 470 being pulled.

In some embodiments, once catheter 421 has been steered toward anchormount 461 in response to pulling guide member 472, guide member 472 isfurther pulled and catheter 421 is pushed distally, in the direction asindicated by the arrow, in order to advance distal tapered end 429 ofcatheter 421 toward channel 460 of anchor mount 461.

Reference is now made to FIGS. 19C-E, which are schematic illustrationsof an anchoring system 2600, in accordance with an embodiment of thepresent invention. FIG. 19C shows a bar 710 disposed within channel 460.Typically, bar 710 is disposed angularly with respect to an axis ofchannel 460, and at the base of the channel. It is to be noted that bar710 is disposed substantially in parallel with the longitudinal axis ofsegment 440 (or segment 430) by way of illustration and not limitation.For example, bar 710 may be disposed perpendicularly to the axis ofsegment 440, i.e., the axis which runs from the first and secondopenings in the lateral wall of segment 440 between which channel 460extends.

Anchoring system 2600 comprising an anchor advancement structure 2620,e.g., a rod or a tube, which is reversibly coupled to anchor 740 via anapplicator 741. Typically, anchor 740 comprises a helical element whoseproximal end is tightly wrapped around a distal projection 743 ofapplicator 741 coupled to a distal end of advancement structure 2620. Insome embodiments, anchor 740 has a tendency to expand radially. By beingadvanced through the lumen of catheter 421, radial expansion of anchor740 is inhibited as anchor 740 is advanced therein. Anchoring system2600 is advanced partially within channel 460, as shown in FIG. 19C.

It is to be noted that applicator 741 is shown by way of illustrationand not limitation, and that that scope of the present inventionincludes the use of anchor 740 independently of applicator 741. In suchan embodiment, the proximal end of anchor 740 is tightly wrapped arounda distal end of advancement structure 2620 and is decoupled therefrom ina manner as will be described hereinbelow with reference to thedecoupling of anchor 740 from projection 743 of applicator 741.

Reference is now made to FIG. 19D. Anchoring of anchor 740 begins whenthe physician rotates advancement structure 2620 about a longitudinalaxis thereof, as indicated by the arrow. Such rotation corkscrews adistal portion of the helical element around and beyond bar 710 andsubsequently into annulus 40 of the patient.

Reference is again made to FIG. 19C. As described hereinabove, channel460 has a diameter between about 0.8 mm and 2.5 mm, typically 1.8 mm.Diameter is thus sized in order to enable passage of anchor 740 throughchannel 460. Typically, anchor 740 configured for passage throughchannel 460 has a diameter D3 of between about 0.5 mm and 2.4 mm, e.g.,1.6 mm. Typically, each coil of the coiled, helical element has adiameter D4 of between about 0.2 mm and 0.6 mm, e.g., 0.3 mm.

Typically, the helical element of anchor 740 is shaped to define atleast two adjacent distal rotational subunits 720 and at least twoadjacent proximal rotational subunits 730. A distance Di1 (e.g., betweenabout 0.3 mm and about 2.0 mm) between adjacent distal rotationalsubunits 720 is typically greater than a distance Di2 (e.g., betweenabout 0 mm and about 0.6 mm) between adjacent proximal rotationalsubunits 730. Typically, a diameter of bar 710 is less than distance Di1and greater than distance Di2. Distance Di1 enables distal rotationalsubunits 720 to be corkscrewed around and beyond bar 710 andsubsequently into annulus 40 of the patient. Distance Di2 is typicallyless than a diameter of bar 710, and therefore restricts proximalrotational subunits 730 from being corkscrewed fully around bar 710 andinto annulus 40.

During an attempt to corkscrew proximal rotational subunits 730 aroundbar 710, bar 710 restricts the rotation of subunits 730 therearound andapplies a counterforce to a torque applied by rotation of structure2620. The counterforce applied by bar 710 expands proximal subunits 730radially such that subunits 730 are no longer wrapped tightly around theprojection 743 of applicator 741. Following the expansion of subunits730, anchor 740 is released from projection 743 of applicator 741,typically by pulling on structure 2620 while continuing to apply arotational, helix-expanding force to proximal subunits 730. Structure2620 and applicator 741 coupled thereto is then pulled proximally withinthe lumen of catheter 421 and extracted from within the body of thepatient, as shown in FIG. 19E. During the removal of structure 2620 fromheart 20, guide member 470 typically remains within system 400, and itis later decoupled from anchor mount 461.

In some embodiments of the present invention, a few coils of the helicalelement are wrapped around projection 743, while the remaining coilsextend distally from a distal end of projection 743. Typically, asmaller number of coils are wrapped around projection 743 than thenumber of coils that extend distally from the distal end of projection743 and are not wrapped around projection 743. As shown by way ofillustration and not limitation, three coils are wrapped aroundprojection 743, while four coils are disposed distally to the distal endof projection 743. The coils wrapped around projection 743 generallyprovide enough frictional force to maintain their position aroundprojection 743 of applicator 741.

In some embodiments, a protrusion (not shown) is typically disposedalong projection 743 adjacent to the proximal-most tip of the helicalelement of anchor 740. During initial implantation of the anchor withinannulus 40 of the patient (i.e., as structure 2620 is rotated), theprotrusion applies a circumferentially-directed pushing force to theproximal-most tip of the helical element. By pushing on theproximal-most tip of the helical element, the protrusion typically addsto the frictional force described above, in order to rotate anchor 740.One or both of these forces enable a distal end of anchor 740 topuncture annulus 40. As anchor 740 is advanced into tissue of annulus40, a portion of proximal rotational subunits of anchor 740 slidesdistally along projection 743 and away from the protrusion.

Following implantation within annulus 40 of distal rotational subunits720, the distal end of projection 743 is impeded by bar 710. Thephysician continues to rotate structure 2620 such that the proximal-mosttip of anchor 740 continues to slide distally from the protrusion whilethe entire anchor 740 continues to be advanced distally within tissue ofannulus 40.

During the continued rotation of structure 2620, fewer rotationalsubunits are wrapped around projection 743, thereby reducing frictionbetween anchor 740 and projection 743. After a sufficient number ofrotations, the minimal friction between anchor 740 and projection 743enables the physician to pull on structure 2620 in order to applicator741 from anchor 740.

As shown in FIG. 19E, once anchor 740 has been implanted within tissueof the annulus, catheter 421 is moved away from anchor mount 461responsively to the pulling on a different guide member 470, as will bedescribed hereinbelow, and to the proximal retracting of catheter 421.

Reference is now made to FIGS. 20A-B, which are perspective schematicillustrations of catheter 421 of system 400 anchoring annuloplastystructure 408 to annulus 40, in accordance with respective embodimentsof the present invention. Catheter 421 is advanced toward anchor mount461 of segment 430 in order to anchor segment 430 to annulus 40 at thebase of anteromedial leaflet 34. A second guide member 474 of theplurality of guide members 470 is pulled in order to steer catheter 421toward anchor mount 461 coupled to guide member 474. Once distal taperedend 429 is advanced partially within channel 460 of anchor mount 461, ananchoring system advances an anchor through the lumen of catheter 421,through the lumen of distal tapered end 429, through channel 460, andsubsequently into tissue of the annulus of the patient, as describedhereinabove with reference to FIG. 19A-E.

As guide member 474 is pulled, the remaining guide members 470 that arenot being pulled are released, in order to provide catheter 421 freedomto move toward guide member 474 and anchor mount 461 coupled thereto. Asshown in FIG. 20A, portions of guide members 470 not being pulled andthat are disposed distally to and in the vicinity of ring 427 are pulledtoward anchor mount 461 coupled to guide member 470. In conjunction withthe steering of catheter 421, catheter 421 is pushed distally in orderto be advanced distally toward the anchor mount to which it is beingsteered.

FIG. 20B shows segments 430 and 440 anchored to annulus 40. A respectiveanchor 740 has been passed through each channel 460 of each anchor mount461. In order to anchor structure 408 to annulus 40, catheter 421 issteered toward each anchor mount 461 by pulling on the respective guidemember 470 coupled to each anchor mount. When distal end 429 of catheter421 is positioned at a given anchor mount, an anchor is passed throughthe lumen of catheter 421 from a site outside the body of the patientand is advanced through catheter 421 by an anchor advancement system.

Catheter 421 may be steered toward the anchor mounts in any sequencethereof. For example, by pulling on a guide member coupled to an anchormount of segment 440, catheter 421 may be steered first toward segment440 in order to anchor structure 408 to annulus 40 at the base ofposterolateral leaflet 32. The physician may then want to anchorstructure 408 to annulus 40 at the base of anteromedial leaflet 34 bypulling on a guide wire coupled to an anchor mount of segment 430. Insome embodiments, each guide member 470 is colorized in order to enablethe physician to determine toward which anchor mount, and thus, to whichlocation along annulus 40, catheter 421 is being steered in response tothe pulling of a given guide member.

For some embodiments in which system 400 comprises a handle assemblycoupled to advancement catheter 410, as described hereinabove, theproximal ends of each guide member 470 are pulled and released by atleast one switch mechanism coupled to the handle. In some embodiments,each guide member 470 is controlled by a respective switch, and eachswitch is labeled with a suitable label indicating a position alongstructure 408 to which the guide member is coupled. For example, guidemembers 470 coupled to segment 440 may be labeled P₁ to P_(n), and guidemembers 470 coupled to segment 430 may be labeled A₁ to A_(n).

In some embodiments, catheter 421 is preloaded with a plurality ofanchors, e.g., helical anchors or anchors as shown herein, or any othersuitable anchor. When distal end 429 is steered toward each anchor mount461, a pushing rod pushes on the proximal-most anchor in order to applya force to the distal-most anchor disposed within the lumen of catheter421 until the distal-most anchor is pushed through channel 460 of therespective anchor mount 461.

Typically, following anchoring of structure 408 to the annulus byimplanting every anchor within the annulus, a cutting means is advancedthrough catheter 421. Catheter 421 is steered toward each anchor mount461 (i.e., in a manner as described hereinabove) and the cutting meanscuts the respective guide member coupled to each mount toward whichcatheter 421 is steered. As such, each guide member 470 is decoupledfrom the respective anchor mount 461.

In some embodiments, catheter 421 is extracted from within the body ofthe patient, and an overtube comprising a cutting means disposed thereinis slid along each one of guide members 470 and toward the respectiveanchor mount to which the guide member is coupled. The cutting meansthen cuts the guide member, and the cutting means and the guide memberare then extracted from within the body of the patient. Subsequently,the overtube is then reintroduced within the body of the patient bybeing slid along a second one of the guide members in order to decouplethat guide member from the annuloplasty structure.

In some embodiments, once catheter 421 has been steered to a firstlocation of the annuloplasty structure by pulling on a first one ofguide members 470, and the anchor advancement structure (a) advances theanchor through catheter 421 and toward the annulus, (b) facilitatesanchoring of the annuloplasty structure to the annulus, and (c) isdecoupled from the anchor, the anchor advancement structure is extractedfrom within catheter 421. Subsequently, the cutting means is introducedwithin catheter 421 and is advanced through catheter 421 toward theanchor mount coupled to the first guide member. The cutting means cutsthe guide member coupled to the anchor mount and is then extracted fromwithin catheter 421 together with the cut guide member. Catheter 421 isthen steered toward a second location of the annuloplasty structure bypulling on a second guide member 470. A second anchor is advanced to thesecond location and anchors the annuloplasty structure to the annulus atthe second location. Following the anchoring, the second guide member iscut as described hereinabove. As such, each guide member 470 issystematically cut following implanting of the respective anchor in thevicinity of the location along the annuloplasty structure to which therespective guide member is coupled.

In some embodiments, a respective distal portion of each guide member470 (i.e., a portion of guide member 470 that is proximal to the portionof guide member 470 that is coupled to anchor mount 461) comprises amaterial configured to dissolve after being exposed within heart 20 ofthe patient for a period of time, e.g., between 15 minutes and 90minutes. In such an embodiment, following anchoring of anchors 740 toannulus 40 as described hereinabove, the respective distal portions ofeach guide member 470 dissolves, thereby decoupling guide member 470from the respective anchor mount 461. Each guide member 470 is thenpulled from its proximal end until its distal end is extracted fromwithin the body of the patient.

In some embodiments, after anchoring annuloplasty structure 408 toannulus 40, one of control wires 480 or 490, e.g., control wire 480, isextracted from within segments 430 and 440 when the physician pulls on afirst end of wire 480. Subsequently, the physician replaces control wire490 with a contracting wire, e.g., a tensile suture, (not shown) by (a)tying a first end of the contracting wire to a first end of wire 490,and then (b) pulling on a second end of wire 490. The physician holdsonto a second end of the contracting wire and pulls wire 490 until thefirst end of the contracting wire has replaced control wire 490 insegments 430 and 440, e.g., until the second end of the contracting wireis once again exposed outside the body of the patient. An intracorporealportion of the contracting wire remains disposed within both segments430 and 440. The contracting wire comprises a flexible and/orsuperelastic material, e.g., nitinol, polyester, ePTFE, PTFE, stainlesssteel, or cobalt chrome, and is configured to reside chronically withinsegments 430 and 440. In some embodiments, the contracting wire iscoated with polytetrafluoroethylene (PTFE). In some embodiments, thecontracting wire comprises a braided polyester suture (e.g., Ticron).Additionally, the contracting wire is configured to withstand cardiacforces and constant motion of segments 430 and 440 that result from themotion of annulus 40. As such, the contracting wire typically has arelatively thick diameter of between about 0.1 mm and about 1.0 mm,typically between about 0.2 mm and about 0.4 mm.

In some embodiments, two contracting wires reside chronically withinsegments 430 and 440. In such an embodiment, a first tensile suturereplaces control wire 480, and a second tensile suture replaces controlwire 490. Control wires 480 and 490 are replaced as describedhereinabove.

In any embodiment, using tactile feedback, or echocardiography, andoptionally in combination with fluoroscopic imaging, first and secondends of the contracting wire(s) are pulled to an extent that is based on(a) the level of dilation of the preoperative mitral valve, and/or (b)real-time monitoring of regurgitation minimization.

Typically, for embodiments in which a contracting wire is used, a lockis advanced around the first and second ends of the contracting wire andsecures together the ends of the contracting wire, and thereby securessegments 430 and 440 of annuloplasty structure 408, thereby defining itsfinal configuration within annulus 40 of mitral valve 30. The excessportions of the contracting wire are clipped proximally to the lock andare extracted from the body via catheter 404. Following clipping, firstand second clipped ends of the contracting wire remain accessible forfuture tightening together of segments 430 and 440 upon need therefor.In some embodiments, the first and second ends of the contracting wireare located using fluoroscopy or any other method described herein.

Reference is now made to FIGS. 17G-J, 18A-B, 19A-E, and 20A-B. It is tobe noted that two annuloplasty ring segments 430 and 440 are shown byway of illustration and not limitation. For example, annuloplastystructure 408 may comprise only one segment of segments 430 and 440. Insome embodiments, annuloplasty structure 408 may comprise one elongatesegment having a length of the combined lengths L1 and L2 (shown in FIG.17H) of segments 430 and 440, respectively, or any other suitable lengthaccording to the needs of a given patient, e.g., according to the extentof dilation of the annulus of the mitral valve.

It is to be additionally noted that use of a helical anchor 740 isdescribed herein by way of illustration and not limitation, and that thescope of the present invention includes the use of other apparatus foranchoring annuloplasty structure 408 to annulus 40. For example, anchor740 may comprise a screw, harpoon, barb, or any other anchoringstructure or anchor known in the art. In some embodiments, anchor 740comprises a wire configured to penetrate annulus 40 in a generallystraight configuration and to subsequently assume a curved configurationonce inside tissue of annulus 40. It is to be noted that any anchoringstructure, anchor and/or anchoring system described herein withreference to FIGS. 1, 4, 5A, 5C, 12, 13A-E, 14A-B, and 15 may be used toanchor structure 408 independently of or in combination with bar 710shown in FIGS. 19B-E. It is to be noted that anchor mount 461 shown inFIGS. 19A-E may be used independently of or in combination with bar 710.In some embodiments, channel 1200 described hereinabove with referenceto FIG. 11 may be used independently of or in combination with anchormount 461 shown in FIGS. 19A-E. It is to be further noted that anchormounts 461 shown in FIGS. 17G-J, 18A-B, 19A-E, and 20A-B may compriseany one of anchor mounts 461 shown in FIGS. 3-4, 5A-C, and 8-10.

It is to be further noted that segments 430 and 440 are shown ascomprising mounts 461 by way of illustration and not limitation. Forexample, segments 430 and 440 may each comprise only one elongatecompressible subunit 450, and each guide member 470 may be coupled tosegments 430 and 440 at any respective suitable location along thecompressible subunit 450.

By reducing a circumference of annulus 40, leaflets 32 and 34 are drawntoward one another to prevent recurring dilation of mitral valve 30,restore leaflet coaptation, and reduce mitral regurgitation.

It is to be noted that in some embodiments of the present invention,guide members 470 comprise a screw at a distal end thereof. In such anembodiment, each guide member 470 is screwed in to a respective anchormount 461. Following the steering of catheter 421 toward the anchormount and the anchoring of the annuloplasty structure to the annulus ofthe patient, the guide member is decoupled from the anchor mount byrotating the proximal end of the guide member from outside the body ofthe patient. The guide member is then extracted from the body of thepatient via catheter 404.

It is to be noted that anchor mount 461 shown in FIGS. 1, 3, 4, 5A, 5C,and 8-10 may be used in combination with any of the annuloplastystructures described herein. In some embodiments, a given annuloplastystructure may comprise a plurality of identical anchor mounts 461. Insome embodiments, a given annuloplasty structure may comprise aplurality of various types of anchor mounts 461 described herein.

It is to be noted that the scope of the present invention is not limitedto minimally-invasive procedures (e.g., transcatheter procedures such aspercutaneous or intercostal penetration procedures), and includesapplications in which system 400 is applied in invasive procedures suchas open-heart surgery.

It is to be noted that the annuloplasty structures described herein maybe advanced toward the annulus using a percutaneous approach, aminimally-invasive approach and/or an open-heart approach.

Reference is again made to FIGS. 17A-J, 18A-B, 19A-E, and 20A-B. It isto be noted that system 400 is shown as being used in a percutaneoustranscatheter access to the left atrium of the patient by way ofillustration and not limitation. It is to be noted that system 400 maybe used for anchoring annuloplasty structure 408 to annulus 40 during anopen-heart procedure. For example, the left atrium may be exposedfollowing an incision in a wall of heart 20. As mitral valve 30 isexposed, the patient is connected to a cardiopulmonary bypass pump whichmaintains the circulation of blood and the oxygen content of thepatient's body during the exposing of valve 30. Catheter 404 is placedin the left atrium and segments 430 and 440 are pushed from withinadvancement catheter 410. In some embodiments, segments 430 and 440 aredisposed externally to catheter 410 prior to placing catheter 404 in theleft atrium. Segments 430 and 440 are then anchored to annulus 40 asdescribed hereinabove. The wall of heart 20 is sutured around catheter404, typically using a purse stitch, and the patient is disconnectedfrom the cardiopulmonary bypass pump in order to restore function toheart 20. In such an embodiment, the physician is able to reduce thecircumference of valve 30 in response to feedback from fluoroscopicand/or ultrasound real-time imaging of the function of valve 30 in abeating heart. Typically, the physician reduces the circumference whileviewing the mitral regurgitation in real-time and tightens structure 408responsively to the extent to which the regurgitation is reduced. Forembodiments in which a minimally-invasive approach is used, system 400may be introduced into the heart either through an intercostal accessfrom the left side of the patient or through an intercostal access fromthe right side of the patient.

Reference is again made to FIGS. 17A-J, 18A-B, 19A-E, and 20A-B. In someembodiments, a distal end of each guide member 470 may be fixedlycoupled to a distal portion of catheter 421, while a distal portion ofeach guide member 470 (i.e., a portion of guide member 470 proximal tothe distal end thereof) is reversibly coupled to respective segments 430and 440 by being looped within respective portions of segments 430 and440 that are typically adjacent to channel 460 of each respective anchormount 461. Such looping of the guide member creates a channel forslidable motion of the guide member. Remaining portions of therespective guide members 470 are disposed (a) within catheter 410 andrun proximally alongside catheter 421, or in some embodiments, (b)within respective secondary lumens of multilumen catheter 420. In someembodiments, the remaining portions of guide members 470 are passedthrough respective channels within ring 427 of catheter 421. It is to benoted that in such an embodiment, catheter 421 may be used independentlyof ring 427.

In such an embodiment, catheter 421 is steered toward a first locationalong either segment in response to pulling of a guide member 470coupled to the segment at the first location (as described hereinabove).As the guide member is pulled, the distal portion of guide member 470slides within the channel thereby (a) allowing the remaining portions ofguide member 470 to be fed proximally within catheter 410, and (b)pulling the distal end of guide member 470, and thereby catheter 421,toward the first location. An anchor is then passed through catheter421, as described hereinabove, and catheter 421 facilitates anchoring ofstructure 408 to the annulus at the first location.

Once catheter 421 has facilitated anchoring of annuloplasty structure408 to the annulus using a plurality of anchors, catheter 421 isextracted from within the body of the patient by being pulledproximally. As catheter 421 is pulled, the physician releases theproximal ends of guide members 470, and guide members 470, coupled atdistal ends thereof to catheter 421, are pulled together with catheter421. As catheter 421 is pulled, the proximal ends of guide members 470are fed into advancement catheter 410 and toward the annuloplastystructure. The proximal ends of the guide members then trail the distalends of the guide members as they are looped through the annuloplastystructure and then fed back through advancement catheter 410. As guidemembers 470 are pulled, they are slid from within their respectivechannels, and are thereby decoupled from structure 408.

FIGS. 21-22 are schematic illustrations of a handle assembly 2800configured for use in an open-heart and/or a minimally-invasiveprocedure to deliver annuloplasty structure 100 as described hereinabovewith reference to FIG. 1, in accordance with an embodiment of thepresent invention. Handle assembly 2800 comprises a handle 2802 andsemi-flexible multitube portion 2808 coupled at a proximal end thereofto a distal end of handle 2802. Multitube portion 2808 comprises aplurality of tubes 2810 coupled and bound together by stabilizing rings2812 and 2820. In some embodiments, a sheath surrounds tubes 2810 and ishermetically sealed at a distal end thereof to ring 2820 and at aproximal end thereof to a distal end of handle 2802. A respective distalend of each tube 2810 is coupled to structure 100 via a respectiveanchor mount 461. As such, the respective distal portions of tubes 2810are flexible such that each tube 2810 branches radially. It is to benoted that a contracting wire is disposed within structure 100 (asdescribed hereinabove with reference to FIG. 1), and is not shown forclarity of illustration. In some embodiments, handle assembly 2800 isdisposable.

As shown in FIG. 21, a distal end 2840 of each tube 2810 is positionedagainst a first lateral surface of a respective anchor mount 461 inalignment with a proximal opening of channel 460 of anchor mount 461.Typically, a longitudinal axis of channel 460 is transverse with respectto the longitudinal axis of anchor mount 461. FIG. 22 shows contractingwire 110 of annuloplasty structure 100 coupled to tubes 2810. It is tobe noted that compressible subunits 450 and anchor mounts 461 (shown inFIG. 21) are not shown for clarity of illustration. Each distal end 2840of tubes 2810 is coupled to a contracting wire coupling element 2830,i.e., an extension or projection, at a proximal end thereof. Eachcontracting wire coupling element 2830 is shaped to define a hole at adistal portion thereof configured for slidable passage therethrough ofat least a portion of contracting wire 110. As shown in FIG. 21, eachcontracting wire coupling element 2830 passes through an opening (e.g.,a second channel, a hole, or a groove that is distinct from channel 460and has a longitudinal axis that is transverse with respect to thelongitudinal axis of anchor mount 461) in a respective anchor mount 461.Each contracting wire coupling element 2830 is configured to surroundcontracting wire 110 passing through mount 461 and enables slidableadvancement therethrough of contracting wire 110.

As shown in FIG. 22, tubes 2810 and distal ends 2840 thereof are shapedto define a hollow lumen 2805 configured for passage of a respectiveanchor through each tube 2810, through distal end 2840, through channel460 of anchor mount 461, and subsequently into tissue of the patient.FIG. 21 shows helical anchors 740 coupled to structure 100 via mounts461. A cross-sectional illustration of proximal end 2801 of handle 2802(FIG. 22) shows proximal end 2801 being shaped to define a plurality ofproximal openings lumens 2803. Handle 2802 is shaped to define aplurality of lumens 2803 whose distal ends are accessed by respectiveproximal ends of tubes 2810. In some embodiments, each lumen 2803 islabeled at proximal end 2801 with a suitable label indicating to whichportion of the annulus the anchor passed through a given lumen will beanchored. For example, lumens 2803 that are configured to deliverrespective anchors to the annulus at the base of the anteromedialleaflet, are labeled A₁-A_(n), in accordance with the number of desiredanchoring sites along the annulus at the base of the anteromedialleaflet. Similarly, lumens 2803 that are configured to deliverrespective anchors to the annulus at the base of the posterolateralleaflet, are labeled P₁-P_(n), in accordance with the number of desiredanchoring sites along the annulus at the base of the posterolateralleaflet.

An anchor is advanced into each lumen 2803 through a respective openingin proximal end 2801 of handle 2802. An anchor advancement system, e.g.,a rod as described hereinabove, advances each anchor through arespective lumen 2803, through tube 2810 accessing lumen 2803, andtoward anchor mount 461 coupled to that tube. In some embodiments, tubes2810 are preloaded with a respective anchor, and once annuloplastystructure 100 is positioned at the annulus, an anchor advancement rod isadvanced through each lumen in order to facilitate advancing of theanchor into tissue of the patient. In some embodiments, tubes 2810 areeach preloaded with a respective anchor and a respective rod coupled ata distal end thereof to each anchor. A proximal end of each rod isaccessible from proximal end 2801 of handle 2802 by a physician who isable to push and/or rotate the rod in order to facilitate advancing ofthe anchor into tissue of the patient.

A portion of contracting wire 110 is configured to be disposed within alumen of structure 100, as described hereinabove. The remaining portionsof contracting wire 110 are slidably disposed within (a) housing 610,(b) a tube 2811 of tubes 2810, and (c) handle 2802. Handle 2802comprises first, second, and third rotating rings 2804, 2806, and 2807,respectively. Typically, a portion, e.g., an end, of a first end ofcontracting wire 110 is coupled to second rotating ring 2806, and aportion, e.g., an end, of a second end of contracting wire 110 iscoupled to third rotating ring 2807. Once anchors 740 have been anchoredto tissue of the patient, and structure 100 has been anchored thereby tothe annulus, a portion of contracting wire 110 is pulled in order toreduce the perimeter/size of the portion of contracting wire 110 that isdisposed within structure 100. Contracting wire 110 is pulled when thefirst and/or second ends thereof are drawn proximally in response torotating rings 2806 and/or 2807. For example, as ring 2806 is rotated, aportion of the first end of contracting wire 110 is wrapped around athreaded element (not shown) disposed within handle 2802 and pullscontracting wire 110 proximally. As wire 110 is pulled proximally, theportion of wire 110 disposed within the lumen of structure 100 slidesthrough the holes of contracting wire coupling elements 2830, and aportion of the portion of wire 110 that was originally disposed withinthe lumen of structure 100 slides proximally out of the lumen ofstructure 100 and toward handle 2802. In some embodiments, ring 2806 maybe rotated as ring 2807 remains stationary, or vice versa. In someembodiments, rings 2806 and 2807 are rotated opposite directions.

Typically, ring 2804 locks rings 2806 and 2807 in place, thereby lockingcontracting wire 110 in a given perimeter as defined by the rotating ofrings 2806 and 2807. It is to be noted that three rings 2804, 2806, and2807 are shown by way of illustration and not limitation.

Using tactile feedback, or echocardiography, and optionally incombination with fluoroscopic imaging, the first and second ends ofcontracting wire 110 are pulled to an extent that is based on (a) thelevel of dilation of the preoperative mitral valve, and/or (b) real-timemonitoring of regurgitation minimization. For embodiments in whichstructure 100 comprises a ratchet mechanism, as described hereinabovewith reference to FIGS. 1, 2A-B, 3, 4, 5A-C, 6A-B, and 7, the ratchetmechanism maintains the ratcheted perimeter of structure 100 followingthe pulling of wire 110. Contracting wire 110 is then pulled from withinthe lumen of structure 100 by cutting a first portion of wire 110 andthen pulling on a first end of contracting wire 110, e.g., by pullingproximally on assembly 2800.

In some embodiments, the first and second ends of contracting wire 110are exposed proximally to rings 2806 and 2807, respectively. In such anembodiment, following the adjustment of annuloplasty structure 100 byrotating rings 2806 and 2807, ring 2804 is rotated in order to unlockrings 2806 and 2807 which are, in turn, allowed to rotate so as tounwind the portion of contracting wire 110 from the threaded element inhandle 2802. One of the ends of the contracting wire is then pulled inorder to remove contracting wire 110 from structure 100. A first end ofcontracting wire 110 is pulled such that the second end of thecontracting wire is pulled (a) distally through tube 2811, (b) throughhousing 610, (c) through each hole of contracting wire coupling elements2830, (d) back through housing 610, (e) pulled proximally back throughtube 2811, until the second end of contracting wire 110 is exposedoutside the body of the patient.

In some embodiments, the first and second ends of wire 110 are fixedlycoupled to rings 2806 and 2807. In such an embodiment, in order toremove contracting wire 110 from within structure 100, tube 2811 is cuttogether with at least one portion of wire 110, and wire 110 is thenpulled from within the lumen of structure 100. By pulling on wire 110and freeing wire 110 from within structure 100 and from contracting wirecoupling elements 2830, handle assembly 2800 is decoupled from structure100.

Once contracting wire 110 is removed from within the holes ofcontracting wire coupling elements 2830, tubes 2810 are decoupled fromstructure 100 by pulling handle 2802 and/or tubes 2810 proximally suchthat contracting wire coupling elements 2830 are pulled from withinanchor mounts 461. Handle assembly 2800 is pulled proximally leavingstructure 100 coupled to the annulus of the patient.

In some embodiments, compressible subunits 450 comprise a coil, and theanchor used to anchor structure 100 to the annulus comprises a helicalcoil comprising coils which are coiled around a portion of coils oftubular, compressible subunits 450 of the annuloplasty structure andsubsequently through the tissue of the annulus of the patient. In suchan embodiment, the annuloplasty structure does not comprise anchormounts 461, and the distal ends of tubes 2810 are positioned at a firstlateral surface of compressible subunits 450 of the annuloplastystructure. During the manufacture of assembly 2800, the annuloplastystructure is coupled to each tube 2810 by passing a respectivecontracting wire coupling element 2830 between adjacent coils ofcompressible subunits 450. Contracting wire 110 is then fed through therespective holes defined by each contracting wire coupling element 2830.Following the coiling of the coils of the anchor around a portion ofcoils of compressible subunits 450, the contracting wire is pulled fromwithin the lumen of the annuloplasty structure, and from within eachhole of contracting wire coupling elements 2830. Handle assembly 2800 isthereby detached from the annuloplasty structure and can be pulledproximally therefrom.

It is to be noted that although helical anchors 740 are shown, the scopeof the present invention includes the use of any anchor describedherein.

In some embodiments, annuloplasty structure 100 does not comprise anchormounts 461 but rather comprises a braided mesh. In either embodiment inwhich structure comprises or lacks anchor mounts 461, prior toadvancement of structure 100 by handle assembly 2800, a plurality ofsutures are sutured at respective locations along the annulus of thevalve. Respective ends of each of the sutures are then threaded atrespective locations through structure 100. Structure 100 is then slidalong the sutures and toward the annulus of the valve by being pushed byhandle assembly 2800. Once positioned at the annulus, the sutures arelocked in place at the exposed lateral surface of structure 100.

In some embodiments, a bead is slid distally along each suture, and issecured in place by crimping, an adhesive, or a ratcheting mechanism,thereby locking the suture in place proximal to structure 100. Theremaining portions of the suture are then cut proximally to the bead. Insome embodiments, respective portions of one suture or of two adjacentsutures are knotted together in order to lock the suture(s) in place.The remaining portions of the suture(s) are then cut proximally to theknot.

It is to be noted that although structure 100 is shown as being coupledto handle assembly 2800, the scope of the present invention includes theuse of handle assembly 2800 to advance structure 408 as describedhereinabove with reference to FIGS. 17G-J, 18A-B, 19A-E, and 20A-B. Forexample, handle assembly 2800 may advance segments 430 and/or 440.

For embodiments in which a minimally-invasive approach is used, assembly2800 may be introduced into the heart either through an intercostalaccess from the left side of the patient or through an intercostalaccess from the right side of the patient.

It is to be noted that handle assembly 2800 (FIGS. 21 and 22) may beused for anchoring the annuloplasty structures described herein to theannulus during an open-heart procedure. For example, the left atrium maybe exposed following an incision in a wall of the heart. As the mitralvalve is exposed, the patient is connected to a cardiopulmonary bypasspump which maintains the circulation of blood and the oxygen content ofthe patient's body during the exposing of the valve. Once theannuloplasty structure is positioned along the annulus of the valve andanchored thereto, the wall of the heart is sutured around the tubularportions of handle assembly 2800 (i.e., multitube portion 2808 ofassembly 2800), typically using a purse stitch, and the patient isdisconnected from the cardiopulmonary bypass pump in order to restorefunction to the heart. The physician is able to reduce the perimeter ofthe annulus in response to feedback from fluoroscopic and/or ultrasoundreal-time imaging of the function of the valve in a beating heart.Typically, the physician reduces the perimeter while viewing the mitralregurgitation in real-time and tightens the annuloplasty structureresponsively to the extent to which the regurgitation is reduced.

FIGS. 23A-B are schematic illustrations of an annuloplasty structuresystem 3100 comprising a tubular ratchet mechanism 3101, in accordancewith an embodiment of the present invention. Typically, ratchetmechanism 3101 is surrounded by a compressible, tubular surrounding 450.Ratchet mechanism 3101 comprises a first tubular element 3102 and asecond tubular element 3106 spaced apart from each other at first endsthereof. Tubular element 3102 is coupled at a second end thereof to afirst tubular coupling member 3105, and tubular element 3106 is coupledat a second end thereof to a second tubular coupling member 3107. Asshown in FIG. 23B, first tubular coupling member 3105 comprises a firstcoupling site 3122 configured for coupling thereto a first end ofcompressible, tubular surrounding 450 (FIG. 23A), and second tubularcoupling member 3107 comprises a second coupling site 3124 configuredfor coupling thereto a second end of compressible, tubular surrounding450 (FIG. 23A).

During the manufacture of system 3100, while holding a first end ofcontracting wire 110 in place outside system 3100, a second end ofcontracting wire 110 is fed through (a) a hole 3120 defined by secondtubular coupling member 3107, (b) second tubular coupling member 3107,(c) tubular element 3106, (d) tubular element 3102, (e) first tubularcoupling member 3105, (f) a portion of second tubular coupling member3107, and finally back through hole 3120. Typically, contracting wire110 is configured for slidable advancement within system 3100.

Typically, during open-heart and minimally-invasive procedures, system3100 is advanced toward the annulus of the mitral valve of the patientin the configuration shown in FIG. 23A, i.e., first and second ratchettubular coupling members 3105 and 3107, respectively, are coupledtogether. For embodiments in which system 3100 is used during apercutaneous procedure (and in some embodiments, during open-heart andminimally-invasive procedures), system 3100 is disposed within anadvancement catheter in a linear configuration thereof. That is, (a)compressible, tubular surrounding 450 is disposed linearly, therebydefining a longitudinal axis thereof, (b) tubular elements 3102 and 3106are disposed coaxially along the longitudinal axis, (c) first and secondtubular coupling members 3105 and 3107, respectively, are not coupledtogether, but rather are disposed at opposite ends of system 3100 alongthe longitudinal axis, and (d) contracting wire 110 extendslongitudinally within the advancement catheter between first and secondtubular coupling members 3105 and 3107 while respective first and secondends of contracting wire 110 are disposed outside the body of thepatient.

In such an embodiment, system 3100 is transcatheterally advanced towardthe left atrium in a linear configuration thereof while first and secondends of contracting wire 110 are disposed outside the body of thepatient. As system 3100 is pushed from within the advancement catheterand is disposed within the left atrium of the patient, the first andsecond ends of contracting wire 110 are pulled, thereby pulling firstand second tubular coupling members 3105 and 3107 toward each other. Inresponse to continued pulling of contracting wire 110, first and secondtubular coupling members 3105 and 3107 are coupled and locked together,and system 3100 assumes a substantially circular configuration, as shownin FIG. 23A.

Typically, first tubular element 3102 has a diameter that is larger thana diameter of second tubular element 3106 such that second tubularelement 3106 is allowed to slide through first tubular element 3102.First tubular element 3102 is shaped to define a plurality of firstengaging elements (e.g., teeth) 3110 at a receiving portion 3104. Secondtubular element 3106 is shaped to define a plurality of second engagingelements (e.g., indented portions 3112) at a feeding portion 3108thereof. Typically, in response to continued pulling of contracting wire110, as feeding portion 3108 (i.e., the first end, of second tubularelement 3106) is initially fed through receiving portion 3104 (i.e., thefirst end, of first tubular element 3102), a first indented portion ofindented portions 3112 is slid through receiving portion 3104 until itis aligned and locks in place with a first one of teeth 3110 ofreceiving portion 3104.

In response to additional force applied to tubular elements 3102 and3106 by continued pulling of contracting wire 110, the first indentedportion of indented portions 3112 is disengaged from the first tooth ofteeth 3110 and is advanced toward the second tooth of teeth 3110.Typically, pulling on contracting wire 110 controls the spatialrelationship between tubular elements 3102 and 3106 which, in turn,control the structural configuration of system 3100. Thus, a perimeterof system 3100 is modulated, i.e., reduced, in response to thecompression of surrounding 450 by the inward, radial force applied dueto the pulling of contracting wire 110.

It is to be noted that the plurality of teeth 3110 is provided such thattubular elements 3102 and 3106 of ratchet mechanism 3101, and therebycompressible, tubular surrounding 450, lock in place and maintainrespective ratcheted perimeters thereof. Such a locking mechanism isapplied so as to enable system 3100 to accommodate various sizes ofdilated annuli of given patients. Additionally, ratchet mechanism 3101facilitates: (1) positioning and anchoring of structure system 3100 tothe dilated annulus while compressible surrounding 450 has a firstperimeter thereof, (2) contracting of the dilated annulus in response tothe contracting of ratchet mechanism 3101, and (3) maintaining of thecontracted state of the annulus while tubular elements 3102 and 3106(and thereby surrounding 450) have a second perimeter thereof that istypically smaller than the first perimeter.

Typically, compressible, tubular surrounding 450 comprises a coil, andthe anchor used to anchor system 3100 to the annulus comprises a helicalcoil comprising coils which are coiled around a portion of coils ofcompressible, tubular surrounding 450 and subsequently through thetissue of the annulus of the patient, as described hereinabove.

In some embodiments, compressible, tubular surrounding 450 comprises abraided mesh, e.g., metal or fabric such as polyester. In such anembodiment, any anchor described herein may be passed through thebraided mesh, and subsequently through the tissue of the annulus,thereby (a) anchoring system 3100 to the annulus, and (b) couplingsystem 3100 to the anchor. Alternatively, a plurality of sutures may beused to anchor system 3100 to the annulus of the patient.

Once system 3100 is anchored to the annulus of the patient, usingreal-time monitoring, tactile feedback, or echocardiography, andoptionally in combination with fluoroscopic imaging, contracting wire110 is pulled. Consequently, the leaflets are drawn toward one anotherin accordance with the level of dilation of the preoperative mitralvalve. Thus, generally, the normal structural configuration is returnedto the leaflets, effecting a reduction in mitral valve perimeter/sizeand regurgitation. As contracting wire 110 is pulled, ratchet mechanism3101 locks system 3100 in place so that system 3100, and thereby theannulus of the patient, assumes and maintains a desired perimeter. Whilea first end of contracting wire 110 is freed, a second end of wire 110is then pulled from a site outside the body of the patient untilcontracting wire 110 is removed from system 3100 and from the body ofthe patient.

It is to be noted that anchors described herein for passage through thebraided mesh of the annuloplasty structure, or configured for coilingaround a portion of coils of coiled compressible subunits 450, have adiameter of between 0.5 mm and 3.5 mm, e.g., 1.6 mm.

It is to be further noted that systems described herein for treatment ofdilated mitral valves may be used to treat valves other than mitralvalve 30, mutatis mutandis. For example, system 400 and structures 100and 408 may be used to treat an aortic valve of the patient or atricuspid valve. In some embodiments, systems described herein for usewith a dilated annulus may be applied in order to treat dilated venousvalves.

It is to be still further noted that systems described herein fortreatment of mitral valves may be used to treat other annular muscleswithin the body of the patient. For example, the systems describedherein may be used in order to treat a sphincter muscle within a stomachof the patient.

It is also to be noted that the scope of the present invention includethe use of the anchors described herein in order to anchor intrabodyapparatus other than annuloplasty structures.

Reference is now made to FIGS. 24A-F, which are schematic illustrationsof a system 4400 for repairing a mitral valve 4030, being advanced intoa left atrium of a patient, in accordance with an embodiment of thepresent invention. Typically, a catheter 4404 (FIG. 24B) is advancedinto the left atrium of the patient using a percutaneous endovascularapproach typically combined with continuous monitoring byelectromagnetic and/or sound waves, e.g., fluoroscopy, transesophagealecho, and/or echocardiography, to maintain real-time orientation of adistal tip of the catheter within the heart of the patient. Typically,catheter 4404 is transseptally advanced into the left atrium.

Catheter 4404 typically comprises a 13 F catheter, although another sizemay be appropriate for a given patient. In some embodiments, catheter4404 is advanced through vasculature of the patient and into the rightatrium using a suitable point of origin typically determined for a givenpatient. For example:

(1) Catheter 4404 is introduced into the femoral vein of the patient,through the superior vena cava, into the right atrium of the heart,transseptally through the fossa ovalis, and finally into the leftatrium;

(2) Catheter 4404 is introduced into the basilic vein, through thesubclavian vein to the superior vena cava, into the right atrium,transseptally through the fossa ovalis, and finally into the leftatrium; or

(3) Catheter 4404 is introduced into the external jugular vein, throughthe subclavian vein to the superior vena cava, into the right atrium,transseptally through the fossa ovalis, and finally into the leftatrium.

In some embodiments, catheter 4404 is advanced through an inferior venacava 4022 of the patient (as shown) and into the right atrium using asuitable point of origin typically determined for a given patient.

FIG. 24A shows a guide wire 4402 being advanced into the right atrium ofthe patient. Advancement of wire 4402 typically precedes advancement ofcatheter 4404 into the right atrium of the patient. Wire 4402 comprisesa semi-rigid wire which provides a guide for the subsequent advancementof catheter 4404 therealong and into the right atrium of the patient, asshown in FIG. 24B. Once catheter 4404 has entered the right atrium,guide wire 4402 is retracted and extracted from within the body of thepatient (FIG. 24C). In FIG. 24D, catheter 4404 is pushed distally untilit reaches the interatrial septum of heart 4020 of the patient.

(In this context, in the specification and in the claims, “proximal”means closer to the orifice through which catheter 4404 is originallyplaced into the vasculature of the patient, and “distal” means furtherfrom this orifice.)

As shown in FIG. 24E, a resilient needle 4406 is advanced throughcatheter 4404 and into heart 4020 of the patient. In order to advancecatheter 4404 transseptally into the left atrium, needle 4406 firstpunctures the septum of heart 4020 such that an opening is created whichfacilitates passage of catheter 4404 therethrough and into the leftatrium. Subsequently, a dilator (not shown) is advanced along needle4406 and toward the septum of heart 4020. Typically, the dilator isshaped to define a hollow shaft for passage along needle 4406, thehollow shaft being shaped to define a tapered distal end. This tapereddistal end is first advanced through the hole created by needle 4406.The hole is enlarged when the gradually increasing diameter of thedistal end of the dilator is pushed through the hole in the septum. Theadvancement of catheter 4404 through the septum and into the left atriumis followed by the extraction of the dilator from within catheter 4404(FIG. 24F).

FIG. 24G is a schematic illustration of a first segment 4430 and asecond segment 4440 of an annuloplasty structure 4408 being advancedalong catheter 4404, in accordance with an embodiment of the presentinvention. Segments 4430 and 4440 are configured to be chronicallyimplanted within heart 4020 along an annulus 4040 of mitral valve 4030.Typically, segments 4430 and 4440 comprise a biocompatible material,e.g., nitinol, titanium, silicone, polytetrafluoroethylene (PTFE),and/or polyester graft material. Additionally, segments 4430 and 4440comprise accordion-like, compressible subunits 450 which facilitatebending of the segments into a suitable configuration and compressing ofthe segments when they are later drawn toward one another.

In some embodiments of the present invention, segments 4430 and 4440comprise coils made of stainless steel, e.g., type 304 or type 316.Suitable coil shapes include round wire coils or flat wire coils.

Prior to advancing segments 4430 and 4440 into the left atrium of thepatient, segments 4430 and 4440 are loaded into an advancement catheter4410 in a substantially linear configuration, as shown in FIG. 24G. Thelinear configuration defines a longitudinal axis of segments 4430 and4440 of structure 4408. Segments 4430 and 4440 are typically advancedinto the left atrium of the patient during a single transcatheteradvancement.

During advancement of segment 4430 within advancement catheter 4410,segment 4430 has a length L10 between about 10 mm and about 50 mm, e.g.,20 mm. Length L10 of segment 4430 typically corresponds with a portionof annulus 4040 at the junction between annulus 4040 and the base of theanteromedial leaflet of valve 4030. Similarly, second segment 4440 isdesignated to be anchored to annulus 4040 at the base of theposterolateral leaflet, and thus is sized in accordance therewith. Forexample, segment 4440 may have a length L20 of between about 20 mm andabout 80 mm, e.g., 40 mm. The respective lengths of segments 4430 and4440 enable the segments to dynamically support the mitral valve inaccordance with the relative motion of the anteromedial andposterolateral leaflets. Typically, segments 4430 and 4440 each have adiameter L30 of between about 1 mm and about 5 mm, typically betweenabout 2.5 mm and about 3.5 mm.

Typically, segments 4430 and 4440 are shaped to define a lateral wall4462 that has at least one flexible hollow lumen configured for slidingadvancement of at least one control wire therethrough. As shown, a firstcontrol wire 4480 and a second control wire 490 are disposed within boththe first and second segments 4430 and 4440. Typically, wires 4480 and4490 function to position and adjust a relative disposition andconfiguration of segments 4430 and 4440 with respect to a configurationof annulus 4040 of valve 4030. Additionally, the structural and spatialconfigurations of each segment are controlled independently by arespective one of the first and second control wires 4480 and 4490. Suchfunctions of wires 4480 and 4490 are described hereinbelow. As such, adiameter of control wires 4480 and 4490 (e.g., between about 0.2 mm andabout 0.4 mm, typically, between 0.25 mm and 0.3 mm) provides the wireswith the strength to control structure 408. Typically, control wires4480 and 4490 comprise a resilient material capable of providing apulling force to segments 4430 and 4440, e.g., nitinol or Teflon. Insome embodiments, control wires 4480 and 4490 are Teflon-coated.

In some embodiments, first and second control tubes are disposed withinboth the first and second segments. Typically, the first and secondcontrol tubes are configured to function similarly to control wires 4480and 4490 described herein.

Typically, lateral wall 4462 of segments 4430 and 4440 is shaped toprovide a first portion 4464 and a second portion 4466 generally atopposite sites of the segment when viewed in cross-section (e.g., at 12o'clock and 6 o'clock). First and second segments 4430 and 4440 ofannuloplasty structure 4408 each comprise at least one channel 4460.Channel 4460 is configured to extend from first portion 4464, throughthe given segment, to second portion 4466. A respective flexible andlongitudinal guide member 4470 is partially disposed within each channel4460 and is used to facilitate anchoring of annuloplasty structure 4408,as described hereinbelow.

Typically, guide member 4470 is configured to facilitate advancementtherealong of a respective anchoring structure (described hereinbelow).The anchoring structure is typically advanced along guide member 4470,through channel 4460, and is ultimately anchored into annulus 4040 ofmitral valve 4030, thereby anchoring the segment to annulus 4040.Typically, guide member 4470 comprises a flexible metal wire, e.g.,nitinol or stainless steel. In some embodiments, guide member 4470comprises a suture comprising an artificial fiber, e.g., nylon,polypropylene, Kevlar, Teflon, or polyester. Typically, each guidemember 4470 has a diameter of between about 0.05 mm and about 0.2 mm,e.g., 0.1 mm.

Prior to advancing segments 4430 and 4440 into the left atrium of thepatient, advancement catheter 4410 is preloaded with segments 4430 and4440, with control wires 4480 and 4490, with guide members 4470, andwith a multilumen catheter 420 which is disposed proximally to segments4430 and 4440. Thus, segments 4430 and 4440 are simultaneously conveyedtoward heart 20, during a single transcatheter advancement. Typically,advancement catheter 4410 comprises a 12 F catheter, although othersizes may be appropriate depending on the size of catheter 4404.

FIGS. 24H and 24I show deployment of first segment 4430 of the segmentedannuloplasty ring, in accordance with an embodiment of the presentinvention. Segments 4430 and 4440 are in a linear configuration withinadvancement catheter 4410 when catheter 4410 is advanced within catheter4404 and initially enters the left atrium. As shown in FIG. 24H, adistal end of catheter 4410 emerges from within catheter 4404.

Segment 4430 maintains its linear configuration as it is initiallypushed from within catheter 4410.

As shown by way of illustration and not limitation, each guide member4470 is looped around a bar disposed within each channel 4460. Thepurpose of this bar is described hereinbelow.

Typically, first and second segments 4430 and 4440 of structure 4408 areultimately made to assume a somewhat round configuration that resemblesan annuloplasty ring in structure and function.

As shown in FIG. 24I, control wires 4480 and 4490 are tightly pulledproximally, applying a force to segment 4430 and compressing segment4430 so that it is made to assume a curved configuration. The curvedconfiguration is thus achieved as compressible subunits 4450 arecompressed in response to the pulling of control wires 4480 and 4490.Typically, compressible subunits 450 are compressed generally inparallel with the longitudinal axis of segment 4430. Such a curvedconfiguration minimizes the possibility for segment 4430 to prematurelycontact walls of heart 4020: (1) during deployment of system 4400 withinthe left atrium, and (2) prior to positioning segments 4430 and 4440along annulus 4040.

It is to be noted that in some embodiments, segments 4430 and 4440 ofannuloplasty structure 4408 comprise a shape-memory alloy, e.g.,nitinol. In these embodiments, segments 4430 and 4440 are introducedwithin catheter 4410 in a straight configuration, and are each biased toassume a generally semi-circular configuration once expanded from withincatheter 4410. Annuloplasty structure 4408 thus assumes a somewhat roundconfiguration typically independently of the application of a proximalforce to control wires 4480 and 4490. In such an embodiment, controlwires 4480 and 4490 are used instead to expand the segments byseparating at least a part of segment 4430 from at least a part ofsegment 4440.

Reference is now made to FIG. 24J, which is a schematic illustration ofsystem 4400 comprising annuloplasty structure 4408 and multilumencatheter 4420, in accordance with an embodiment of the presentinvention. As shown, each control wire 4480 and 4490 is coupled to arespective adjustment wire 4482 and 4492. Adjustment wires 4482 and 4492are configured to contribute to adjusting a relative disposition ofsegments 4430 and 4440 once inside the left atrium of heart 4020. Thefunctions of wires 4482 and 4492 are described in more detailhereinbelow.

Typically, multilumen catheter 4420 is shaped to define a primary lumen4426 and secondary lumens 4422 and 4424. The flexible and longitudinalguide members 4470 are disposed within primary lumen 4426 and areexposed outside the body of the patient proximally to catheter 4404.Since, in some embodiments, a respective anchoring structure is advancedalong each of guide members 4470, primary lumen 4426 typically has adiameter D10 of between about 1.0 mm to about 3.0 mm (e.g., 1.6 mm). Thediameter D10 of lumen 4426 allows passage therethrough of at least oneanchoring structure at a given time.

First and second portions of control wire 4490 and a portion ofadjustment wire 4482 are disposed within secondary lumen 4422 (asshown), while first and second portions of control wire 4480 and aportion of adjustment wire 4492 are disposed within secondary lumen 4424(as shown). Multilumen catheter 4420 separates and isolates control wire4480 from control wire 4490 and separates and isolates adjustment wire4482 from adjustment wire 4492, thereby enabling the physician todistinguish between each of control wires 4480 and 4490 and betweenadjustment wires 4482 and 4492. Thus, catheter 4420 helps facilitateindependent control by the physician of each of the wires whichultimately determine the relative positioning of structure 4408 withinthe left atrium of heart 4020.

Reference is now made to FIGS. 25A and 25B, which are schematicillustrations of first segment 4430 of structure 4408 being advancedfrom within catheter 4410, as described hereinabove with reference toFIGS. 24H and 24I, in accordance with an embodiment of the presentinvention.

Reference is now made to FIG. 25C, which is a schematic illustration ofthe deployment and expansion of segments 4430 and 4440, in accordancewith an embodiment of the present invention. Control wires 4480 and 4490are shown disposed within at least one hollow lumen of both first andsecond segments 4430 and 4440 of annuloplasty structure 4408, therebycoupling the segments. In some embodiments, each of segments 4430 and4440 is shaped to provide a first lumen configured for slidingadvancement therethrough of wire 4480, and a second lumen configured forsliding advancement of wire 4490 (configuration not shown). First andsecond portions of control wire 4480 emerge from within segments 4430and 4440 at respective first ends 432 and 442 of segments 4430 and 4440.The first and second portions of control wire 4480 are disposed withinsecondary lumen 4424 such that first and second ends of wire 4480 areexposed and controllable from outside the body of the patient.Similarly, first and second portions of control wire 4490 emerge fromwithin segments 4430 and 4440 at respective second ends 4434 and 4444 ofsegment 4430 and 4440. The first and second portions of control wire4490 are disposed within secondary lumen 4422, such that first andsecond ends of wire 4490 are exposed and controllable from outside thebody of the patient.

In some embodiments, multilumen catheter 4420 is shaped to providesecondary lumens 4423 and 4425, as shown. Typically, lumens 4423 and4425 are provided for passage of supplementary instruments, e.g., forsuction and/or irrigation, therethrough and into the left atrium of thepatient.

Following the deployment, segments 4430 and 4440 are expanded by beingseparated in accordance with the shape of the dilated annulus.Adjustment wire 4482 extends from secondary lumen 4422 and is coupled ata distal end thereof to control wire 4480. Typically, adjustment wire4482 is coupled to a portion of wire 4480 that is disposed at a junctionbetween respective second ends 4434 and 4444 of segments 4430 and 4440.Similarly, adjustment wire 4492 extends from secondary lumen 4424 and iscoupled at a distal end thereof to control wire 4490. Typically,adjustment wire 4492 is coupled to a portion of control wire 4490 thatis disposed at a junction between respective first ends 4432 and 4442 ofsegments 4430 and 4440. Typically, adjustment wires 4482 and 4492 areirreversibly coupled, e.g. knotted or otherwise fixed, to control wires4480 and 4490, respectively. In some embodiments, adjustment wires 4482and 4492 are looped around control wires 4480 and 4490, respectively.

The separating of segments 4430 and 4440 occurs when the physicianpushes control wires 4480 and 4490 while pushing adjustment wires 4482and 4492. Thus, adjustment wires 4482 and 4492 provide an auxiliarypushing force which helps expand segments 4430 and 4440. Such pushing ofthe control wires feeds greater portions of control wires 4480 and 4490into segments 4430 and 4440. The relaxed configuration of control wires4480 and 4490 is shown in FIG. 25C, while the taut configuration thereofis shown in FIG. 25B. Typically, segments 4430 and 4440 expand annularlyas increasing lengths of control wires 4480 and 4490 are pushed and fedinto segments 4430 and 4440.

In some embodiments of the present invention, adjustment wires 4482 and4492 are pulled to elevate portions of segments 4430 and 4440, such thatthe segments conform to the shape of annulus 4040. For example, pullingadjustment wire 4482 elevates the portion of control wire 4480 which isdisposed between segments 4430 and 4440. In response to the pulling,second ends 4434 and 4444 of segments 4430 and 4440, respectively, areelevated.

Control wires 4480 and 4490 enable the physician to control a relativedisposition of second ends 4434 and 4444 and first ends 4432 and 4442 ofsegments 4430 and 4440, respectively. For example, distal pushing of thefirst and second ends of control wire 4480 distances second ends 4434and 4444 of segments 4430 and 4440, respectively. Similarly, distalpushing of the first and second ends of control wire 4490 distancesfirst ends 4432 and 4442 of segments 4430 and 4440, respectively. It isto be noted that the use of two discrete control wires allows forindependent control of the distance that separates first ends 4432 and4442 and the distance that separates second ends 4434 and 4444 ofsegments 4430 and 4440.

Additionally, pulling on respective ends of control wires 4480 and 4490shapes segments 4430 and 4440 in accordance with the curved structuralconformation of annulus 4040 at a given site destined for anchoring of arespective one of the segments thereto. For example, pulling on a firstend of control wire 4490 and on a first end of control wire 4480 curvessegment 4430 by drawing together second end 4434 and first end 4432,respectively, of segment 4430. Thus, segment 4430 is compressed at leastin part, and is made to assume a shape according to the curvature of theannulus at the base of the anteromedial leaflet.

Reference is now made to FIG. 25D, which is a schematic illustration ofthe deployment and expansion of segments 4430 and 4440 as describedhereinabove with reference to FIG. 25C, with the exception thatstructure 4408 is optionally rotated as appropriate about an axis ofannulus 4040, in accordance with an embodiment of the present invention.Guided by echocardiography, the physician assesses the relativedisposition of segments 4430 and 4440 with respect to annulus 4040 ofheart 4020. Multilumen catheter 4420 is configured to be rotatable 360degrees about a longitudinal axis thereof. By rotating multilumencatheter 4420, the segments are positioned properly with respect to theannulus. That is, segment 4440 is positioned above a portion of annulus4040 at the base of the posterolateral leaflet, while segment 4430 ispositioned above a portion of annulus 4040 at the base of theanteromedial leaflet.

FIG. 25E shows catheter 4410 comprising a steering wire 4500, inaccordance with an embodiment of the present invention. Typically, adistal end of steering wire 4500 is coupled to a distal end of catheter4410. A proximal end of wire 4500 is disposed at a site outside the bodyof the patient, enabling the physician to steer the distal end ofcatheter 4410. Following the deployment and expansion of annuloplastystructure 4408, multilumen catheter 4420 is retracted slightly withinadvancement catheter 4410. Retracting multilumen catheter 4420 frees thelumen of the distal end of catheter 4410, thereby restoring flexibilityto the distal end of catheter 4410 and enabling proper steering thereof.Structure 4408 is pushed toward annulus 4040 by pushing on both catheter4410 and on wires 4480 and 4490. Additionally, the structure is properlyaligned with annulus 4040 by steering and/or rotating the distal tip ofcatheter 4410.

FIG. 25F shows system 4400 following the aligning of segments 4430 and4440 with annulus 4040, in accordance with an embodiment of the presentinvention. Segment 4440 is aligned against the base of posterolateralleaflet 4032 at the annulus, and segment 4430 is aligned against thebase of anteromedial leaflet 4034 at the annulus. Segments 4430 and 4440are shown prior to anchoring thereof to annulus 4040. Multilumencatheter 4420 is shown in a slightly retracted state within catheter4410.

Reference is now made to FIGS. 26A and 26B, which are schematicillustrations of system 4400 comprising an anchoring system 4600, inaccordance with an embodiment of the present invention. Once advancementcatheter 4410 has positioned segments 4430 and 4440 in their properorientation with respect to annulus 4040, catheter 4410 is retractedslightly within catheter 4404 and a distal end of multilumen catheter4420 is exposed. At a site proximal to catheter 4404, and outside thebody of the patient, the physician slides a first anchoring system 4600around both ends of a first flexible and longitudinal guide member 4470.Anchoring system 4600 is advanced through primary lumen 426 ofmultilumen catheter 4420. Anchoring system 4600 is advanced along guidemember 4470 and subsequently inserted, in part, into channel 4460, asshown in FIG. 26B.

Reference is now made to FIGS. 27A-E, which are schematic illustrationsof anchoring system 4600, in accordance with an embodiment of thepresent invention. FIG. 4A shows a bar 4710 disposed within channel4460. Typically, bar 4710 is disposed perpendicularly to an axis ofchannel 4460, and at the base of the channel. It is to be noted that bar4710 is disposed parallel to the longitudinal axis of segment 4440 (orsegment 4430) by way of illustration and not limitation. For example,bar 4710 may be disposed perpendicularly to the axis of segment 4440.Guide member 4470 is disposed within channel 4460 and is reversiblycoupled to structure 4408 via bar 4710. Typically, guide member 4470 islooped around bar 4710 prior to the advancement of structure 4408 intothe body of the patient. When structure 4408 is disposed within heart4020, both ends of guide member 4470 are exposed outside the body of thepatient, thus enabling the physician to slide anchoring system 4600around both ends of member 4470 and therealong toward annulus 4040 ofheart 4020.

FIG. 27B shows anchoring system 4600 comprising an outer tube 4610housing an advancement tube 4620, which is reversibly coupled to ananchoring structure 4740. Typically, anchoring structure 4740 comprisesa helical element whose proximal end is tightly wrapped around a distalend of advancement tube 4620. Outer tube 4610 typically prevents radialexpansion of anchoring structure 4740 within primary lumen 4426 ofmultilumen catheter 4420 as structure 4740 is advanced therein.Anchoring system 4600 is advanced within channel 4460, as shown in FIG.27C.

Reference is now made to FIG. 27D. Anchoring of anchoring structure 4740begins when the physician rotates advancement tube 4620 about alongitudinal axis thereof. Such rotation corkscrews a distal portion ofthe helical element around and beyond bar 4710 and subsequently intoannulus 4040 of the patient.

Reference is made to FIGS. 27A and 27B. Typically, channel 4460 has adiameter D20, e.g., between about 0.8 mm and 1.2 mm, typically 1.0 mm.Diameter D20 is thus sized in order to enable passage of anchoringstructure 4740 through channel 4460. Typically, anchoring structure 4740has a diameter D30 of between about 0.5 mm and 1.5 mm, e.g., 1 mm.Typically, each coil of the coiled, helical element has a diameter D40of between about 0.05 mm and 0.5 mm, e.g., 0.2 mm.

Reference is again made to FIG. 27B. Typically, the helical element isshaped to define at least two adjacent distal rotational subunits 4720and at least two adjacent proximal rotational subunits 4730. A distanceDi10 (e.g., between about 0.3 mm and about 0.6 mm) between adjacentdistal rotational subunits 4720 is typically greater than a distanceDi20 (e.g., between about 0 mm and about 0.4 mm) between adjacentproximal rotational subunits 4730. Typically a diameter of bar 4710 isless than distance Di10 and greater than distance Di20. Distance Di10enables distal rotational subunits 4720 to be corkscrewed around bar4710 and subsequently into annulus 4040 of the patient. Distance Di20 istypically less than a diameter of bar 4710, and therefore restrictsproximal rotational subunits 4730 from being corkscrewed fully aroundbar 4710 and into annulus 4040.

During an attempt to corkscrew proximal rotational subunits 4730 aroundbar 4710, bar 4710 restricts the rotation of subunits 4730 therearoundand applies a counterforce to a torque applied by rotation of tube 4620.The counterforce applied by bar 4710 expands proximal subunits 4730radially such that subunits 4730 are no longer wrapped tightly aroundthe distal end of tube 4620. Following the expansion of subunits 4730,anchoring structure 4740 is released from tube 4620, typically bypulling on tube 4620 while continuing to apply a rotational,helix-expanding force to proximal subunits 4730. Tube 4620 is thenpulled proximally along guide member 4470 and extracted from within thebody of the patient, as shown in FIG. 27E. During the removal of tube4620 from heart 4020, guide member 4470 typically remains within system4400, although it is optionally removed at the same time as tube 4620.

In some embodiments of the present invention, a few rotational subunitsof the helical element are wrapped around a distal end of tube 4620,while the remaining rotational subunits extend distally from the distalend of tube 4620. Typically, a smaller number of rotational subunits arewrapped around tube 4620 than the number of rotational subunits thatextend distally from the distal end of tube 4620 and are not wrappedaround the distal end of tube 4620. As shown by way of illustration andnot limitation, three rotational subunits are wrapped around the distalend of tube 4620, while four rotational subunits are disposed distallyto the distal end of tube 4620. The rotational subunits wrapped aroundthe distal end of tube 4620 generally provide enough frictional force tomaintain their position around the distal end of tube 4620.

A protrusion (not shown) is typically disposed along the distal end oftube 4620 adjacent to the proximal-most tip of the helical element ofanchoring structure 4740. During initial implantation of the anchoringstructure within annulus 4040 of the patient (i.e., as tube 4620 isrotated), the protrusion applies a circumferentially-directed pushingforce to the proximal-most tip of the helical element. By pushing on theproximal-most tip of the helical element, the protrusion typically addsto the frictional force described above, in order to rotate anchoringstructure 4740. One or both of these forces enable a distal end ofstructure 4740 to puncture annulus 4040. As anchoring structure 4740 isadvanced into tissue of annulus 4040, the proximal end of anchoringstructure 4740 slides distally along the distal end of tube 4620 andaway from the protrusion.

Following implantation within annulus 4040 of distal rotational subunits4720, the distal end of tube 4620 is impeded by bar 4710. The physiciancontinues to rotate tube 4620 such that the proximal-most tip ofanchoring structure 4740 continues to slide distally from the protrusionwhile the entire anchoring structure 4740 continues to be advanceddistally within tissue of annulus 4040. During the continued rotation oftube 4620, fewer rotational subunits are wrapped around the distal endof tube 4620, thereby reducing friction between anchoring structure 4740and the distal end of tube 4620. After a sufficient number of rotations,the minimal friction between structure 4740 and the distal end of tube4620 enables the physician to pull on tube 4620 in order to detach tube4620 from anchoring structure 4740.

It is to be understood that use of a helical anchoring structure 4740 isdescribed herein by way of illustration and not limitation, and that thescope of the present invention includes the use of other apparatus foranchoring annuloplasty structure 4408 to annulus 4040. For example,anchoring structure 4740 may comprise a screw, harpoon, barb, or anyother anchoring structure known in the art. In some embodiments,anchoring structure 4740 comprises a wire configured to penetrateannulus 4040 in a generally straight configuration and to subsequentlyassume a curved configuration once inside tissue of annulus 4040.

Reference is now made to FIGS. 28A-B, which are schematic illustrationsof anchoring system 4600, which anchors segments 4430 and 4440 toannulus 4040 of heart 20, in accordance with an embodiment of thepresent invention. FIG. 28A shows segment 4440 being anchored, viaanchoring system 4600, to annulus 4040 at the base of posterolateralleaflet 4032. A respective anchoring system 4600 is sequentiallyadvanced along each guide member 4470 until both segments 4430 and 4440are anchored to annulus 4040, and tubes 4620 and guide members 4470 arewithdrawn.

As shown, the helical element of anchoring structure 4740 comprises apointed distal tip 4750 configured to puncture tissue of annulus 4040 inorder to enable screwing of structure 4740 within annulus 4040 of thepatient. In some embodiments, distal tip 4750 comprises a barb oranchoring structure 4740 comprises a plurality of barbs, configured toprovide a lock between structure 4740 and annulus 4040.

Following the anchoring of each structure 4740 within annulus 4040, eachguide member 4470 is decoupled from the respective bar 4710. Forembodiments in which guide member 4470 is looped around bar 4710, guidemember 4470 is decoupled from bar 4710 when the physician pulls on afirst end of guide member 4470 from a site outside the body of thepatient. Guide member 4470 slides around bar 4710 until it is extractedfrom within the body of the patient.

In some embodiments, a first end of guide member 4470 comprises amaterial configured to dissolve when exposed within heart 4020 of thepatient. In such an embodiment, guide member 4470 is typically notlooped around bar 4710, rather, it is coupled at its first end to bar4710 while a second end thereof is disposed outside the body of thepatient. Following anchoring of structure 4740 to annulus 4040 asdescribed hereinabove, the first end of guide member 4470 dissolves,thereby decoupling guide member 4470 from bar 4710. Guide member 4470 isthen pulled from its second end until the first end is extracted fromwithin the body of the patient.

In some embodiments, a first end of guide member 4470 is coupled to oneof the segments, prior to placement in the patient's body, by, forexample, passing through channel 4460 and being attached to an externalsurface of the segment. Alternatively, guide member 4470 comprises a“T”-shaped anchor at a distal end of guide member 4470, which passesthrough channel 4460 and inhibits proximal motion of the “T”-shapedanchor through the channel. In such an embodiment, guide member 4470 istypically not looped around bar 4710. Typically, a second end of guidemember 4470 is disposed outside the body of the patient. Followinganchoring of structure 4740 to annulus 4040 as described hereinabove,the physician pulls on the second end of guide member 4470 in order totear the guide member at a pre-weakened point on the guide member,typically slightly proximal to the segment. Guide member 4470 is thenextracted from within the body of the patient while the distal-mostportion of guide member 4470 that is attached to the external surface ofthe segment, or the “T”-shaped anchor, remains disposed within structure4408.

Reference is now made to FIG. 28C, which is a schematic illustration ofsystem 4400, comprising a tensile suture 4800 configured for slidingadvancement through segments 4430 and 4440, in accordance with anembodiment of the present invention. One of control wires 4480 or 4490,e.g., control wire 4480, is extracted from within segments 4430 and 4440when the physician pulls on a first end of wire 4480. Subsequently, thephysician replaces control wire 4490 with tensile suture 4800 by (a)tying a first end of suture 4800 to a first end of wire 4490, and then(b) pulling on a second end of wire 4490. The physician pulls wire 4490until the first end of suture 4800 has replaced control wire 4490 insegments 4430 and 4440, e.g., until suture 4800 is once again exposedoutside the body of the patient. As shown in FIG. 28C, a portion ofsuture 4800 remains disposed within both segments 4430 and 4440. Tensilesuture 4800 comprises a flexible material, e.g., nitinol, Kevlar,titanium, or polytetrafluoroethylene

(PTFE), and is configured to reside chronically within segments 4430 and4440. For example, suture 4800 may comprise a braided polyester suture(e.g., Ticron). Additionally, suture 4800 is configured to withstandcardiac pressures and constant motion of segments 4430 and 4440 thatresult from the motion of annulus 4040. As such, suture 4800 typicallyhas a relatively thick diameter of between about 0.1 mm and about 1.0mm, typically between about 0.3 mm and about 0.6 mm.

In some embodiments, two tensile sutures 4800 reside chronically withinsegments 4430 and 4440. In such an embodiment, a first tensile suturereplaces control wire 4480, and a second tensile suture replaces controlwire 4490. Control wires 4480 and 4490 are replaced as describedhereinabove.

In any embodiment, using tactile feedback and optionally in combinationwith fluoroscopic imaging, first and second ends of suture(s) 4800 arepulled to an extent that is based on (a) the level of dilation of thepreoperative mitral valve, and/or (b) real-time monitoring ofregurgitation minimization.

FIG. 28C shows a lock 4820 being advanced around first and secondportions of suture 4800, in accordance with an embodiment of the presentinvention. Lock 4820 secures together segments 4430 and 4440 ofannuloplasty structure 4408, thereby defining its final configurationwithin annulus 4040 of mitral valve 4030. The excess portions of tensilesuture 4800 are clipped proximally to lock 4820 and are extracted fromthe body via catheter 4404. Following clipping, first and second ends ofsuture 4800 remain accessible for future tightening together of segments4430 and 4440 upon need therefor. In some embodiments, the first andsecond ends of suture 4800 are located using fluoroscopy or any othermethod described herein.

FIG. 28D shows annuloplasty structure 4408 in a closed state, inaccordance with an embodiment of the present invention. By reducing acircumference of annulus 4040, leaflets 4032 and 4034 are lifted and/ordrawn toward one another to prevent recurring dilation of mitral valve4030, restore leaflet coaptation, and reduce mitral regurgitation.

It is to be noted that in an embodiment of the present invention, guidemembers 4470 comprise a screw at a distal end thereof. Guide member 4470in this embodiment is suitable for conveying torque, such that byrotating the proximal end of the guide member from outside the body ofthe patient, the screw at the distal end is screwed into the annulus.Following anchoring of the screw to the annulus of the patient, theguide member is clipped proximally to the screw and is extracted fromwithin the body of the patient. In such an embodiment, guide member 4470is configured to anchor structure 4408 to annulus 4040 independently ofbar 4710 described hereinabove.

It is to be noted that the scope of the present invention is not limitedto minimally-invasive procedures (e.g., transcatheter procedures such aspercutaneous or intercostal penetration procedures), and includesapplications in which system 4400 is applied in invasive procedures suchas open heart surgery.

It is to be further noted that system 4400 may be used to treat valvesother than mitral valve 4030. For example, system 4400 may be used totreat an aortic valve of the patient.

The scope of the present invention includes embodiments described inU.S. patent application Ser. No. 11/950,930 to Gross et al., filed Dec.5, 2007, entitled, “Segmented ring placement,” which published as US2008/0262609, and which is assigned to the assignee of the presentpatent application and is incorporated herein by reference.

Additionally, the scope of the present invention includes embodimentsdescribed in one or more of the following:

-   -   PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral        Valve treatment techniques,” filed Mar. 15, 2006;    -   U.S. Provisional Patent Application 60/873,075 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;    -   U.S. Provisional Patent Application 60/902,146 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed on Feb. 16,        2007;    -   U.S. Provisional Patent Application 61/001,013 to Gross et al.,        entitled, “Segmented ring placement,” filed Oct. 29, 2007;    -   PCT Patent Application PCT/IL07/001503 to Gross et al.,        entitled, “Segmented ring placement,” filed on Dec. 5, 2007,        which published as WO 08/068756;    -   U.S. Provisional Patent Application 61/132,295 to Gross et al.,        entitled, “Annuloplasty devices and methods of delivery        therefor,” filed on Jun. 16, 2008;    -   U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled,        “Adjustable partial annuloplasty ring and mechanism therefor,”        filed on Dec. 22, 2008, which issued as U.S. Pat. No. 8,241,351;    -   U.S. Provisional Patent Application 61/207,908, to Miller et        al., entitled, “Actively-engageable movement-restriction        mechanism for use with an annuloplasty structure,” filed on Feb.        17, 2009;    -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled: “Adjustable repair chords and spool mechanism        therefor,” filed May 4, 2009, which issued as U.S. Pat. No.        8,147,542; and    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” Filed        on May 7, 2009, which issued as U.S. Pat. No. 8,715,342.

All of these applications are incorporated herein by reference.Techniques described herein can be practiced in combination withtechniques described in one or more of these applications.

For some applications, techniques described herein are practiced incombination with techniques described in one or more of the referencescited in the Background section and Cross-References section of thepresent patent application. All references cited herein, includingpatents, patent applications, and articles, are incorporated herein byreference.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. Apparatus, comprising: a plurality ofhelical tissue anchors; and an intracardiac annuloplasty structuredefining a plane of the annuloplasty structure for placement on anannulus of a heart valve, the annuloplasty structure comprising: aplurality of compressible subunits, and a plurality of anchor mountsalternately disposed with respect to the plurality of compressiblesubunits, each anchor mount (a) defining at least one opening forpassage therethrough of a respective one of the plurality of helicaltissue anchors, (b) defining a path for passage therethrough of therespective one of the plurality of helical tissue anchors, the pathbeing aligned along an axis that is at a non-zero angle with respect tothe plane of the annuloplasty structure, and (c) providing a structuralelement in the path for corkscrewing a distal portion of the respectiveone of the plurality of helical tissue anchors therearound.
 2. Theapparatus according to claim 1, wherein the structural element comprisesa bar that is disposed in parallel with the plane of the annuloplastystructure.
 3. The apparatus according to claim 1, wherein the structuralelement is configured to restrict continued corkscrewing of therespective one of the plurality of helical tissue anchors into tissue.4. The apparatus according to claim 1, wherein the annuloplastystructure comprises a contracting wire configured to control astructural configuration of the annuloplasty structure.
 5. The apparatusaccording to claim 1, further comprising a rotatable ring coupled to theannuloplasty structure, such that rotation of the rotatable ringcontracts the annuloplasty structure.
 6. The apparatus according toclaim 5, further comprising a lock ring arranged to lock the rotatablering.
 7. The apparatus according to claim 1, further comprising firstand second rotatable rings coupled to the annuloplasty structure,arranged such that (a) the first rotatable ring is rotatable to contractthe annuloplasty structure while the second rotatable ring remainsstationary, and (b) the second rotatable ring is rotatable to contractthe annuloplasty structure while the first rotatable ring remainsstationary.
 8. The apparatus according to claim 1, further comprising aratchet coupled to the annuloplasty structure, wherein the ratchetmaintains a perimeter of the annuloplasty structure followingcontracting of the annuloplasty structure.
 9. The apparatus according toclaim 1, further comprising one or more longitudinal members reversiblycoupled to the annuloplasty structure at respective locations of theannuloplasty structure, wherein the one or more longitudinal members arearranged such that the one or more longitudinal members are moveable toadjust a configuration of respective parts of the annuloplasty structureat the respective locations of the annuloplasty structure.
 10. Theapparatus according to claim 9, wherein the one or more longitudinalmembers comprise at least first and second longitudinal members coupledto the annuloplasty structure at respective first and second locationsof the annuloplasty structure, and wherein movement of the first one ofthe longitudinal members moves a first part of the annuloplastystructure at the first location with respect to a second part of theannuloplasty structure at the second location.
 11. The apparatusaccording to claim 1, wherein the at least one opening of each anchormount defines first and second openings, and wherein each respective oneof the plurality of helical tissue anchors is moveable through the firstand second openings of each anchor mount.
 12. The apparatus according toclaim 11, wherein the distal portion of the respective one of theplurality of helical tissue anchors is arranged to corkscrew around thestructural element before moving through the second opening.
 13. Theapparatus according to claim 1, wherein a proximal portion of therespective one of the plurality of helical tissue anchors is shaped soas to restrict continued corkscrewing of the helical tissue anchor intotissue.
 14. A method, comprising: advancing into a heart of a patient: aplurality of helical tissue anchors; and an intracardiac annuloplastystructure defining a plane of the annuloplasty structure for placementon an annulus of a heart valve, the annuloplasty structure including: aplurality of compressible subunits, and a plurality of anchor mountsalternately disposed with respect to the plurality of compressiblesubunits, each anchor mount (a) defining at least one opening forpassage therethrough of a respective one of the plurality of helicaltissue anchors, (b) defining a path for passage therethrough of therespective one of the plurality of helical tissue anchors, the pathbeing aligned along an axis that is at a non-zero angle with respect tothe plane of the annuloplasty structure, and (c) providing a structuralelement in the path for corkscrewing a distal portion of the respectiveone of the plurality of helical tissue anchors therearound; andanchoring the annuloplasty structure to the annulus of the heart valveby moving the respective one of the plurality of helical tissue anchorsthrough the path.
 15. The method according to claim 14, furthercomprising, by the structural element, facilitating restricting ofcontinued moving of the respective one of the plurality of helicaltissue anchors into tissue of the annulus beyond a predetermineddistance.
 16. The method according to claim 14, further comprisingcontracting the annuloplasty structure by pulling a portion of acontracting wire coupled to the annuloplasty structure.
 17. The methodaccording to claim 14, further comprising: contracting the annuloplastystructure; and maintaining a perimeter of the annuloplasty structurefollowing the contracting, using a ratchet coupled to the annuloplastystructure.
 18. The method according to claim 14, wherein the at leastone opening defines first and second openings, and wherein moving therespective one of the plurality of helical tissue anchors through thepath comprises moving the respective one of the plurality of helicaltissue anchors through the first and second openings.
 19. The methodaccording to claim 18, wherein moving the respective one of theplurality of helical tissue anchors through the first and secondopenings comprises corkscrewing the distal portion of the respective oneof the plurality of helical tissue anchors around the structural elementbefore moving the distal portion through the second opening.
 20. Themethod according to claim 14, wherein the annuloplasty structure iscoupled to first and second rotatable rings, and wherein the methodfurther comprises: using the first rotatable ring coupled to theannuloplasty structure, contracting the annuloplasty structure while thesecond rotatable ring remains stationary; and using the second rotatablering coupled to the annuloplasty structure, contracting the annuloplastystructure while the first rotatable ring remains stationary.